Rotarix

Rotarix oral suspension in squeezable tube

Manufacturer: GlaxoSmithKline UK
Label last updated: 19 Jun 2026
Source: Official SmPC ↗

Oral rotavirus vaccine, two doses, starting from 6 weeks and complete by 24 weeks. A live weakened virus given by mouth from a squeezable tube.

59 findings, each with the section of the label it comes from.

Ingredients and materials

Human rotavirus RIX4414 strain, live and attenuated, not less than 10^6.0 CCID50 per 1.5 ml doses.2
Produced on Vero cells (a laboratory-grown monkey kidney cell line)s.2
Excipients: sucrose, di-sodium adipate, Dulbecco's Modified Eagle Medium (DMEM, containing phenylalanine, sodium, glucose and other substances), sterile waters.6.1
Contains 1,073 mg of sucrose, 32 mg of sodium, 10 micrograms of glucose and 0.15 micrograms of phenylalanine per dose, all declared as excipients with known effects.2
Because of the sugar content, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this vaccines.4.4
Contains 32 mg sodium and 0.15 micrograms phenylalanine per dose, the latter relevant to phenylketonuria (PKU)s.4.4

Manufacture, storage and handling

Shelf life 3 years in the squeezable tube fitted with a membrane; the vaccine should be used immediately after openings.6.3
Store at 2C to 8C, do not freeze, store in the original package to protect from lights.6.4
Ready to use: no reconstitution or dilution requireds.6.6
Oral use only, administered straight from the tube into the inside of the cheek; it must under no circumstances be injecteds.4.2, 6.6
Must not be mixed with any other vaccines or solutionss.6.6
Discard if foreign particulate matter or abnormal appearance is seens.6.6
Must not be mixed with other medicinal products; no compatibility studies exists.6.2
The course is two doses with at least 4 weeks between them, preferably given before 16 weeks and which must be completed by 24 weeks of ages.4.2
Must not be used in children over 24 weeks of ages.4.2
If an infant spits out or regurgitates most of the dose, a single replacement dose may be given at the same visits.4.2

Safety findings

The label states that data from observational safety studies indicate an increased risk of intussusception, mostly within 7 days after rotavirus vaccination, and professionals should follow up on symptoms such as severe abdominal pain, persistent vomiting, bloody stools, abdominal bloating or high fevers.4.4
Up to 6 additional cases of intussusception per 100,000 infants have been observed, against a background incidence of 25 to 101 per 100,000 infants under one year of age per years.4.8
There is limited evidence of a smaller increased risk following the second doses.4.8
'It remains unclear whether rotavirus vaccines affect the overall incidence of intussusception based on longer periods of follow-up's.4.8
Contraindicated in a history of intussusceptions.4.3
Contraindicated in uncorrected congenital malformation of the gastrointestinal tract that would predispose to intussusceptions.4.3
Contraindicated in severe combined immunodeficiency (SCID) disorders.4.3
Contraindicated in hypersensitivity to the active substance or excipients, and after a previous rotavirus vaccines.4.3
Should be postponed during acute severe febrile illness, and in infants with diarrhoea or vomitings.4.3
There are no data on the safety and efficacy of Rotarix in infants with gastrointestinal illnesses or growth retardation; use may be considered with caution where withholding it entails a greater risks.4.4
Excretion of the vaccine virus in the stools is known to occur, peaking around the 7th days.4.4
Viral antigen particles detected by ELISA were found in 50 per cent of stools after the first dose and 4 per cent after the second; when tested for live vaccine strain, only 17 per cent were positives.4.4
Cases of transmission of the excreted vaccine virus to seronegative contacts have been observed, without causing any clinical symptoms.4.4
Should be given with caution to individuals with immunodeficient close contacts, such as people with malignancies, those otherwise immunocompromised, or those on immunosuppressive therapy; contacts of recent vaccinees should wash their hands after changing nappiess.4.4
Administration to infants with known or suspected immunodeficiency, including in utero exposure to immunosuppressive treatment, should be based on careful consideration of potential benefits and riskss.4.4
The potential risk of apnoea and the need for respiratory monitoring for 48 to 72 hours should be considered in very premature infants born at or before 28 weeks, particularly those with previous respiratory immaturity; vaccination should not be withheld or delayeds.4.4
A protective immune response may not be elicited in all vaccineess.4.4
The extent of protection against other rotavirus strains that were not circulating in the clinical trials 'is currently unknown's.4.4
Rotarix does not protect against gastroenteritis caused by pathogens other than rotaviruss.4.4
No data are available on the use of Rotarix for post-exposure prophylaxiss.4.4
There are no data on safety, immunogenicity or efficacy when Rotarix is given as the first dose and another rotavirus vaccine as the second, or the reverses.4.2
Asymptomatic and mildly symptomatic HIV infections are not expected to affect safety or efficacy, and a study in a limited number of such infants showed no apparent safety problemss.4.4, 4.8
Intussusception is listed as a very rare adverse reaction, with anaphylactic reaction and haematochezia listed at frequency not knowns.4.8
Gastroenteritis with vaccine viral shedding is listed in infants with severe combined immunodeficiencys.4.8
Because it is not intended for use in adults, there are no data on use during pregnancy and lactations.4.6
Breastfeeding does not reduce the protection afforded by Rotarix, so breastfeeding may be continueds.4.6
Overdose has been reported and the adverse event profile was similar to the recommended doses.4.9

Evidence and claims

In a European study of 4,000 subjects, efficacy against any severity of circulating rotavirus strains was 87.1 per cent in the first year and 71.9 per cent in the second; against severe gastroenteritis it was 95.8 per cent then 85.6 per cents.5.1
Efficacy is strongly genotype-dependent and several results are not statistically significant, for example against G2P[4] at any severity (62.0 per cent in year 1, 57.1 per cent in year 2) and G4P[8] in the second year (69.6 per cent), which the label says should be interpreted with cautions.5.1
Efficacy against hospitalisation for rotavirus gastroenteritis was 100 per cent in year one (confidence interval 81.8 to 100) and 92.2 per cent in year twos.5.1
In a Latin American study of more than 20,000 subjects, efficacy against severe rotavirus gastroenteritis was 84.7 per cent in the first year and 79.0 per cent in the seconds.5.1
Several genotype-specific results in the Latin American study were not statistically significant, including G4P[8] at 50.8 per cent in the first years.5.1
Efficacy increased with disease severity, reaching 100 per cent (confidence interval 84.7 to 100) for Vesikari scores of 17 or aboves.5.1
In a preterm infant study, 670 infants of 27 to 36 weeks gestation received Rotarix and 339 received placebo; serious adverse events were seen in 5.1 per cent of Rotarix recipients against 6.8 per cent of placebo recipients, and no cases of intussusception were reporteds.4.8
Safety data come from 23 clinical trials with approximately 106,000 doses given to approximately 51,000 infantss.4.8
In three placebo-controlled trials where Rotarix was given alone, the incidence and severity of solicited events such as diarrhoea, vomiting, loss of appetite, fever, irritability and cough or runny nose were not significantly different from placebos.4.8
Concomitant oral polio vaccine may slightly reduce the immune response to the rotavirus vaccine, but clinical protection against severe rotavirus gastroenteritis was maintained in a trial of more than 4,200 subjectss.4.5
Preclinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicitys.5.3

Document and licensing

Marketing authorisation holder: GlaxoSmithKline UK Limited, Londons.7
First authorised 1 January 2021s.9
Text last revised 10 June 2026s.10
The intussusception risk is stated in absolute numbers as well as described, and the label admits the effect on the overall incidence remains unclears.4.8
Suspected reactions are reported through the MHRA Yellow Card schemes.4.8

Every line above is a summary of a statement in the manufacturer's own label, with the section number it comes from. Nothing has been added from any other source. The full list of flagged sentences is below, as it came out of the document.

Listed ingredients

Section 2 - qualitative and quantitative composition source ↗

1 dose (1.5 mL) contains:
 Human rotavirus RIX4414 strain (live, attenuated)* 
 not less than 10^6.0 CCID50
 *Produced on Vero cells
 Excipients with known effect:
 This product contains 1 073 mg of sucrose, 32 mg of sodium, 10 micrograms of glucose and 0.15 microgram of phenylalanine per dose (see section 4.4).
 For the full list of excipients, see section 6.1.

What these are, in plain English

attenuated - Weakened on purpose so the organism cannot cause the disease in a healthy person.
vero - VERO cells: a laboratory-grown line of kidney cells originally taken from an African green monkey in 1962. Cells, not animal tissue, and they are not present in the finished vaccine.
sucrose - Sugar. Used as a stabiliser so the vaccine keeps its potency in storage.
glucose - A simple sugar, used as a stabiliser.
phenylalanine - An amino acid. People with the inherited condition phenylketonuria (PKU) have to limit it, which is why it is declared.

Other ingredients (excipients)

Section 6.1 source ↗

SucroseSugar. Used as a stabiliser so the vaccine keeps its potency in storage.
Di-sodium AdipateA buffer salt used to hold the acidity steady.
Dulbecco's Modified Eagle Medium (DMEM) (containing phenylalanine, sodium, glucose, and other substances)An amino acid. People with the inherited condition phenylketonuria (PKU) have to limit it, which is why it is declared.
Sterile waterPurified water to the standard used for injected medicines. It is the liquid the other ingredients are dissolved in.

Audit trail: every flagged sentence in the document (57)

These are the sentences the mechanical filter pulled out, in the document's own words, grouped by section. They are what the briefing above was built from, kept here so you can check nothing was left out. Some are fragments and some are technical, which is why the briefing exists.

4.2 Posology and method of administration

There are no data on safety, immunogenicity or efficacy when Rotarix is administered for the first dose and another rotavirus vaccine is administered for the second dose or vice versa.

Section 4.2 Posology and method of administration source ↗
In plain English
- immunogenicity - How strongly the vaccine provokes an immune response. It is measured in the blood, not by how many people avoided the illness.
- efficacy - How well it works in the controlled conditions of a trial.
- no data - The label is stating that no study has measured this. It is a statement about what was tested, not about what was found.
Efficacy, effectiveness and endpointsNo data / not studied matched: efficacy, no data
Rotarix should not be used in children over 24 weeks of age.

Section 4.2 Posology and method of administration source ↗
In plain English
- should not be used - The label says the product should not be given in this situation.
Not recommended, contraindicated or restricted matched: should not be used

4.3 Contraindications

Subjects with uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.

Section 4.3 Contraindications source ↗
In plain English
- intussusception - A rare bowel blockage, mostly in babies, where one part of the gut folds into the next. It is a medical emergency.
Rare or very rare serious events matched: intussusception

4.4 Special warnings and precautions for use

There are no data on the safety and efficacy of Rotarix in infants with gastrointestinal illnesses or growth retardation.

Section 4.4 Special warnings and precautions for use source ↗
In plain English
- efficacy - How well it works in the controlled conditions of a trial.
- no data - The label is stating that no study has measured this. It is a statement about what was tested, not about what was found.
Efficacy, effectiveness and endpointsNo data / not studied matched: efficacy, no data
As a precaution, healthcare professionals should follow-up on any symptoms indicative of intussusception (severe abdominal pain, persistent vomiting, bloody stools, abdominal bloating and/or high fever) since data from observational safety studies indicate an increased risk of intussusception, mostly within 7 days after rotavirus vaccination (see section 4.8).

Section 4.4 Special warnings and precautions for use source ↗
In plain English
- intussusception - A rare bowel blockage, mostly in babies, where one part of the gut folds into the next. It is a medical emergency.
Rare or very rare serious events matched: intussusception
For subjects with a predisposition for intussusception, see section 4.3.

Section 4.4 Special warnings and precautions for use source ↗
In plain English
- intussusception - A rare bowel blockage, mostly in babies, where one part of the gut folds into the next. It is a medical emergency.
Rare or very rare serious events matched: intussusception
Asymptomatic and mildly symptomatic HIV infections are not expected to affect the safety or efficacy of Rotarix.

Section 4.4 Special warnings and precautions for use source ↗
In plain English
- efficacy - How well it works in the controlled conditions of a trial.
Efficacy, effectiveness and endpoints matched: efficacy
When these stools were tested for the presence of live vaccine strain, only 17% were positive.

Section 4.4 Special warnings and precautions for use source ↗

Genetic engineering, vectors and GMOs matched: live
In two comparative controlled trials, vaccine shedding after vaccination with Rotarix liquid formulation was comparable to that observed after vaccination with Rotarix lyophilised formulation.

Section 4.4 Special warnings and precautions for use source ↗
In plain English
- shedding - The vaccine organism being released from the body, for example in nasal mucus, and possibly passing to other people.
Immune system, shedding and transmission matched: shedding
Cases of transmission of this excreted vaccine virus to seronegative contacts of vaccinees have been observed without causing any clinical symptom.

Section 4.4 Special warnings and precautions for use source ↗
In plain English
- transmission - Passing something from one person to another.
Immune system, shedding and transmission matched: transmission
Rotarix should be administered with caution to individuals with immunodeficient close contacts, such as individuals with malignancies, or who are otherwise immunocompromised or individuals receiving immunosuppressive therapy.

Section 4.4 Special warnings and precautions for use source ↗
In plain English
- immunocompromised - Having a weakened immune system, from illness or from medicines such as chemotherapy.
- immunosuppressive - A medicine or treatment that dampens the immune system.
Immune system, shedding and transmission matched: immunocompromised
A protective immune response may not be elicited in all vaccinees (see section 5.1).

Section 4.4 Special warnings and precautions for use source ↗

Efficacy, effectiveness and endpoints matched: immune response
Clinical studies from which efficacy data were derived were conducted in Europe, Central and South America, Africa and Asia (see section 5.1).

Section 4.4 Special warnings and precautions for use source ↗
In plain English
- efficacy - How well it works in the controlled conditions of a trial.
Efficacy, effectiveness and endpoints matched: efficacy
No data are available on the use of Rotarix for post-exposure prophylaxis.

Section 4.4 Special warnings and precautions for use source ↗
In plain English
- no data - The label is stating that no study has measured this. It is a statement about what was tested, not about what was found.
No data / not studied matched: no data

4.5 Interaction with other medicinal products and other forms of interaction

Concomitant administration of Rotarix and oral polio vaccine (OPV) does not affect the immune response to the polio antigens.

Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

Efficacy, effectiveness and endpoints matched: immune response
Although concomitant administration of OPV may slightly reduce the immune response to rotavirus vaccine, clinical protection against severe rotavirus gastro-enteritis was shown to be maintained in a clinical trial involving more than 4 200 subjects who received Rotarix concomitantly with OPV.

Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

Efficacy, effectiveness and endpoints matched: immune response

4.6 Fertility, pregnancy and lactation

There are no data on the use of Rotarix during pregnancy and lactation.

Section 4.6 Fertility, pregnancy and lactation source ↗
In plain English
- no data - The label is stating that no study has measured this. It is a statement about what was tested, not about what was found.
No data / not studied matched: no data

4.8 Undesirable effects

Gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency (SCID) disorder

Section 4.8 Undesirable effects source ↗
In plain English
- shedding - The vaccine organism being released from the body, for example in nasal mucus, and possibly passing to other people.
Immune system, shedding and transmission matched: shedding
* Because these events were reported spontaneously, it is not possible to reliably estimate their frequency.

Section 4.8 Undesirable effects source ↗

Limited, insufficient or inconclusive matched: not possible
Data from observational safety studies performed in several countries indicate that rotavirus vaccines carry an increased risk of intussusception, mostly within 7 days of vaccination.

Section 4.8 Undesirable effects source ↗
In plain English
- intussusception - A rare bowel blockage, mostly in babies, where one part of the gut folds into the next. It is a medical emergency.
Rare or very rare serious events matched: intussusception
It remains unclear whether rotavirus vaccines affect the overall incidence of intussusception based on longer periods of follow-up (see section 4.4).

Section 4.8 Undesirable effects source ↗
In plain English
- intussusception - A rare bowel blockage, mostly in babies, where one part of the gut folds into the next. It is a medical emergency.
Rare or very rare serious events matched: intussusception
Serious adverse events were observed in 5.1% of recipients of Rotarix as compared with 6.8% of placebo recipients.

Section 4.8 Undesirable effects source ↗
In plain English
- placebo - A dummy injection with no active ingredient, used as a comparison group in a trial.
Rare or very rare serious events matched: serious adverse
No cases of intussusception were reported.

Section 4.8 Undesirable effects source ↗
In plain English
- intussusception - A rare bowel blockage, mostly in babies, where one part of the gut folds into the next. It is a medical emergency.
Rare or very rare serious events matched: intussusception

5.1 Pharmacodynamic properties

In clinical trials, efficacy was demonstrated against gastro-enteritis due to rotavirus of the most common genotypes G1P[8], G2P[4], G3P[8], G4P[8] and G9P[8].

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- efficacy - How well it works in the controlled conditions of a trial.
- common - In the label's frequency scale, this means it happened in up to 1 in 10 people studied.
Efficacy, effectiveness and endpoints matched: efficacy
In addition, efficacy against uncommon rotavirus genotypes G8P[4] (severe gastro-enteritis) and G12P[6] (any gastro-enteritis) has been demonstrated.

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- uncommon - In the label's frequency scale, this means it happened in up to 1 in 100 people studied.
- efficacy - How well it works in the controlled conditions of a trial.
Efficacy, effectiveness and endpoints matched: efficacy
Clinical studies have been conducted in Europe, Latin America, Africa and Asia to evaluate the protective efficacy of Rotarix against any and severe rotavirus gastro-enteritis (RVGE).

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- efficacy - How well it works in the controlled conditions of a trial.
Efficacy, effectiveness and endpoints matched: efficacy
Clinical protection was assessed in the ATP cohort for efficacy, which includes all subjects from the ATP cohort for safety who entered into the concerned efficacy follow-up period.

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- efficacy - How well it works in the controlled conditions of a trial.
Efficacy, effectiveness and endpoints matched: efficacy
After two doses of Rotarix, the protective vaccine efficacy observed during the first and second year of life is presented in the following table:

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- efficacy - How well it works in the controlled conditions of a trial.
Efficacy, effectiveness and endpoints matched: efficacy
Vaccine efficacy (%) against any and severe rotavirus gastro-enteritis

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- efficacy - How well it works in the controlled conditions of a trial.
Efficacy, effectiveness and endpoints matched: efficacy
Vaccine efficacy (%) against rotavirus gastro-enteritis requiring medical attention

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- efficacy - How well it works in the controlled conditions of a trial.
Efficacy, effectiveness and endpoints matched: efficacy
Vaccine efficacy (%) against hospitalisation due to rotavirus gastro-enteritis

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- efficacy - How well it works in the controlled conditions of a trial.
Efficacy, effectiveness and endpoints matched: efficacy
Vaccine efficacy during the first year of life progressively increased with increasing disease severity, reaching 100% (95% CI: 84.7;100) for Vesikari scores ≥ 17.

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- efficacy - How well it works in the controlled conditions of a trial.
Efficacy, effectiveness and endpoints matched: efficacy
The protective vaccine efficacy against severe rotavirus (RV) gastro-enteritis requiring hospitalisation and/or rehydration therapy in a medical facility and the genotype specific vaccine efficacy after two doses of Rotarix are presented in the table below:

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- efficacy - How well it works in the controlled conditions of a trial.
Efficacy, effectiveness and endpoints matched: efficacy
# The numbers of cases, on which the estimates of efficacy against G4P[8] were based, were very small (1 case in the Rotarix group and 2 cases in the placebo group)

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- efficacy - How well it works in the controlled conditions of a trial.
- placebo - A dummy injection with no active ingredient, used as a comparison group in a trial.
Efficacy, effectiveness and endpoints matched: efficacy
A pooled analysis of five efficacy studies*, showed a 71.4% (95% CI: 20.1;91.1) efficacy against severe rotavirus gastro-enteritis (Vesikari score ≥ 11) caused by rotavirus G2P[4] genotype during the first year of life.

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- efficacy - How well it works in the controlled conditions of a trial.
Efficacy, effectiveness and endpoints matched: efficacy
The vaccine efficacy against severe rotavirus gastro-enteritis during the first year of life was 61.2% (95% CI: 44.0;73.2).

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- efficacy - How well it works in the controlled conditions of a trial.
Efficacy, effectiveness and endpoints matched: efficacy
The protective vaccine efficacy (pooled doses) observed against any and severe rotavirus gastro-enteritis is presented in the following table:

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- efficacy - How well it works in the controlled conditions of a trial.
Efficacy, effectiveness and endpoints matched: efficacy
Sustained efficacy up to 3 years of age in Asia

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- efficacy - How well it works in the controlled conditions of a trial.
Efficacy, effectiveness and endpoints matched: efficacy
During the first year, significantly fewer subjects in the Rotarix group reported severe rotavirus gastro-enteritis caused by the circulating wild-type RV compared to the placebo group from 2 weeks after Dose 2 up to one year of age (0.0% versus 0.3%), with a vaccine efficacy of 100% (95% CI: 72.2; 100).

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- efficacy - How well it works in the controlled conditions of a trial.
- placebo - A dummy injection with no active ingredient, used as a comparison group in a trial.
Efficacy, effectiveness and endpoints matched: efficacy
The protective vaccine efficacy after two doses of Rotarix observed against severe rotavirus gastro-enteritis up to 2 years of age is presented in the following table:

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- efficacy - How well it works in the controlled conditions of a trial.
Efficacy, effectiveness and endpoints matched: efficacy
Efficacy up to 2 years of age

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- efficacy - How well it works in the controlled conditions of a trial.
Efficacy, effectiveness and endpoints matched: efficacy
Vaccine efficacy (%) against severe rotavirus gastro-enteritis [95% CI]

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- efficacy - How well it works in the controlled conditions of a trial.
Efficacy, effectiveness and endpoints matched: efficacy
Vaccine efficacy (%) against rotavirus gastro-enteritis requiring hospitalisation and/or rehydration therapy in a medical facility [95% CI]

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- efficacy - How well it works in the controlled conditions of a trial.
Efficacy, effectiveness and endpoints matched: efficacy
Vaccine efficacy was 100% (95% CI: 67.5; 100).

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- efficacy - How well it works in the controlled conditions of a trial.
Efficacy, effectiveness and endpoints matched: efficacy
The incidence of severe RV gastro-enteritis associated with the individual genotypes was too small to allow calculation of efficacy.

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- efficacy - How well it works in the controlled conditions of a trial.
Efficacy, effectiveness and endpoints matched: efficacy
The efficacy against severe RV gastro-enteritis requiring hospitalisation was 100% (95% CI: 72.4;100).

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- efficacy - How well it works in the controlled conditions of a trial.
Efficacy, effectiveness and endpoints matched: efficacy
Since the immune response observed after 2 doses of Rotarix liquid formulation was comparable to the immune response observed after 2 doses of Rotarix lyophilised formulation, the levels of vaccine efficacy observed with the lyophilised formulation can be extrapolated to the liquid formulation.

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- efficacy - How well it works in the controlled conditions of a trial.
Efficacy, effectiveness and endpoints matched: efficacy
A relationship between antibody responses to rotavirus vaccination and protection against rotavirus gastro-enteritis has not been established.

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- not been established - There is not yet enough evidence to state a conclusion.
No data / not studied matched: not been established
In three comparative controlled trials, the immune response elicited by Rotarix liquid formulation was comparable to the one elicited by Rotarix lyophilised formulation.

Section 5.1 Pharmacodynamic properties source ↗

Efficacy, effectiveness and endpoints matched: immune response
In observational studies, vaccine effectiveness was demonstrated against severe gastro-enteritis leading to hospitalisation due to rotavirus of common genotypes G1P[8], G2P[4], G3P[8], G4P[8] and G9P[8] as well as the less common rotavirus genotypes G9P[4] and G9P[6].

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- effectiveness - How well it works in ordinary use in the real world.
- common - In the label's frequency scale, this means it happened in up to 1 in 10 people studied.
Efficacy, effectiveness and endpoints matched: effectiveness
Effectiveness after 2 doses in preventing RVGE leading to hospitalisation

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- effectiveness - How well it works in ordinary use in the real world.
Efficacy, effectiveness and endpoints matched: effectiveness
(4) Vaccine effectiveness was calculated using rotavirus-negative hospital control participants (estimates from Taiwan were calculated using combined rotavirus-negative hospital control and non-diarrhoea hospital control participants).

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- effectiveness - How well it works in ordinary use in the real world.
Efficacy, effectiveness and endpoints matched: effectiveness
(5) Vaccine effectiveness was calculated using neighbourhood controls.

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- effectiveness - How well it works in ordinary use in the real world.
Efficacy, effectiveness and endpoints matched: effectiveness
(6) In subjects who did not receive the full course of vaccination, the effectiveness after one dose ranged from 51% (95% CI: 26;67, El Salvador) to 60% (95% CI: 37; 75, Brazil).

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- effectiveness - How well it works in ordinary use in the real world.
Efficacy, effectiveness and endpoints matched: effectiveness
Vaccine effectiveness estimate is based on 41 fully vaccinated cases and 175 fully vaccinated controls.

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- effectiveness - How well it works in ordinary use in the real world.
Efficacy, effectiveness and endpoints matched: effectiveness

6.6 Special precautions for disposal and other handling

If you notice anything abnormal, do not use the vaccine.

Section 6.6 Special precautions for disposal and other handling source ↗

Not recommended, contraindicated or restricted matched: do not use
If you notice anything abnormal, do not use the vaccine.

Section 6.6 Special precautions for disposal and other handling source ↗

Not recommended, contraindicated or restricted matched: do not use

Read the whole document at the source ↗