Trial Outcomes & Findings for To Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK's Oral Human Rotavirus Vaccine in Pre-Term Infants (NCT NCT00420745)
NCT ID: NCT00420745
Last Updated: 2018-06-08
Results Overview
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
COMPLETED
PHASE3
1009 participants
From Day 0 up to 1 month after Dose 2 of Rotarix vaccine/Placebo
2018-06-08
Participant Flow
Participant milestones
| Measure |
Rotarix Group
All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
|
Placebo Group
All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
|
|---|---|---|
|
Overall Study
STARTED
|
670
|
339
|
|
Overall Study
COMPLETED
|
655
|
333
|
|
Overall Study
NOT COMPLETED
|
15
|
6
|
Reasons for withdrawal
| Measure |
Rotarix Group
All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
|
Placebo Group
All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
10
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Recurrent pneumonia & bronchitis
|
0
|
1
|
|
Overall Study
Age limit exceeded for Dose 2
|
1
|
0
|
Baseline Characteristics
To Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK's Oral Human Rotavirus Vaccine in Pre-Term Infants
Baseline characteristics by cohort
| Measure |
Rotarix Group
n=670 Participants
All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
|
Placebo Group
n=339 Participants
All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
|
Total
n=1009 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.5 weeks
STANDARD_DEVIATION 1.77 • n=5 Participants
|
8.5 weeks
STANDARD_DEVIATION 1.78 • n=7 Participants
|
8.5 weeks
STANDARD_DEVIATION 1.77 • n=5 Participants
|
|
Sex: Female, Male
Female
|
327 Participants
n=5 Participants
|
167 Participants
n=7 Participants
|
494 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
343 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
515 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Day 0 up to 1 month after Dose 2 of Rotarix vaccine/PlaceboPopulation: The analyses were performed on the Total Vaccinated Cohort that included all the subjects with at least one study vaccine or placebo administration documented.
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Outcome measures
| Measure |
Rotarix Group
n=670 Participants
All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
|
Placebo Group
n=339 Participants
All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
|
|---|---|---|
|
Number of Subjects Reporting Any Serious Adverse Events (SAEs).
|
34 subjects
|
23 subjects
|
SECONDARY outcome
Timeframe: Within 31 days after any Rotarix vaccine/Placebo dose.Population: The analyses were performed on the Total Vaccinated Cohort that included all the subjects with at least one study vaccine or placebo administration documented.
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Outcome measures
| Measure |
Rotarix Group
n=670 Participants
All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
|
Placebo Group
n=339 Participants
All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
|
|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs), According to Medical Dictionary for Regulatory Activities (MedDRA) Classification.
|
196 subjects
|
138 subjects
|
SECONDARY outcome
Timeframe: Within 15 days after each Rotarix vaccine/Placebo dose.Population: The analyses were performed on the Total vaccinated cohort for the safety and the immunogenicity subset that included all subjects with at least one study vaccine or placebo administered and for whom solicited symptoms were collected.
Solicited symptoms included Diarrhea (3 or more looser than normal stools/day), Fever (axillary temperature ≥ 37.5 degrees Celsius (°C)), Irritability, Loss of appetite, and Vomiting
Outcome measures
| Measure |
Rotarix Group
n=203 Participants
All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
|
Placebo Group
n=100 Participants
All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
|
|---|---|---|
|
Number of Subjects for Whom Each Type of Solicited Symptom Was Reported.
Diarrhea
|
9 subjects
|
5 subjects
|
|
Number of Subjects for Whom Each Type of Solicited Symptom Was Reported.
Fever
|
54 subjects
|
29 subjects
|
|
Number of Subjects for Whom Each Type of Solicited Symptom Was Reported.
Irritability
|
133 subjects
|
66 subjects
|
|
Number of Subjects for Whom Each Type of Solicited Symptom Was Reported.
Loss of appetite
|
81 subjects
|
45 subjects
|
|
Number of Subjects for Whom Each Type of Solicited Symptom Was Reported.
Vomiting
|
52 subjects
|
27 subjects
|
SECONDARY outcome
Timeframe: From Dose 1 up to 1 month after Dose 2 of Rotarix vaccine/PlaceboPopulation: The analyses were performed on the Total Vaccinated Cohort that included all the subjects with at least one study vaccine or placebo administration documented.
Gastroenteritis (GE): diarrhoea with or without vomiting. Rotavirus (RV) GE: A GE episode was a RV GE if a stool sample taken during or not later than 7 days after the episode was RV positive by Enzyme Linked Immunosorbent Assay.
Outcome measures
| Measure |
Rotarix Group
n=670 Participants
All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
|
Placebo Group
n=339 Participants
All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
|
|---|---|---|
|
Number of Subjects for Whom Presence of Rotavirus (RV) Gastroenteritis (GE) Was Detected in Stools.
|
3 subjects
|
2 subjects
|
SECONDARY outcome
Timeframe: At Visit 3, 1 month after Dose 2 of Rotarix vaccine/PlaceboPopulation: The analyses were performed on the According-to-Protocol immunogenicity cohort that included all subjects with at least one study vaccine or placebo administered, for whom immunogenicity data were collected and available and who complied with the inclusion criteria defined in the protocol.
Number of subjects with anti-rotavirus IgA antibody concentration ≥ 20 Units/milliliter (U/mL).
Outcome measures
| Measure |
Rotarix Group
n=147 Participants
All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
|
Placebo Group
n=81 Participants
All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
|
|---|---|---|
|
Seroconversion to Anti-rotavirus Immunoglobulin A (IgA) Antibody.
|
126 subjects
|
13 subjects
|
SECONDARY outcome
Timeframe: At Visit 3, 1 month after Dose 2 of Rotarix vaccine/PlaceboPopulation: The analyses were performed on the According-to-Protocol immunogenicity cohort. The anti-rotavirus IgA antibody GMC for Placebo Group was below the assay cut-off (\<20 U/mL), so could not be computed.
Anti-rotavirus IgA antibody concentrations are given as geometric mean concentrations (GMC) with 95% Confidence Intervals, calculated on all subjects.
Outcome measures
| Measure |
Rotarix Group
n=147 Participants
All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
|
Placebo Group
All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
|
|---|---|---|
|
Serum Anti-Rotavirus IgA Antibody Concentration.
|
202.2 U/mL
Interval 153.1 to 267.1
|
—
|
Adverse Events
Rotarix Group
Placebo Group
Serious adverse events
| Measure |
Rotarix Group
n=670 participants at risk
All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
|
Placebo Group
n=339 participants at risk
All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/670
|
0.59%
2/339
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.15%
1/670
|
0.00%
0/339
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.15%
1/670
|
0.00%
0/339
|
|
Infections and infestations
Bronchiolitis
|
0.45%
3/670
|
1.2%
4/339
|
|
Infections and infestations
Bronchitis
|
0.60%
4/670
|
0.59%
2/339
|
|
Infections and infestations
Bronchopneumonia
|
0.60%
4/670
|
0.29%
1/339
|
|
Congenital, familial and genetic disorders
Coarctation of the aorta
|
0.15%
1/670
|
0.00%
0/339
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/670
|
0.29%
1/339
|
|
Infections and infestations
Dacryocystitis
|
0.15%
1/670
|
0.00%
0/339
|
|
Metabolism and nutrition disorders
Dehydration
|
0.15%
1/670
|
0.00%
0/339
|
|
Gastrointestinal disorders
Diarrhoea
|
0.30%
2/670
|
0.00%
0/339
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/670
|
0.29%
1/339
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/670
|
0.59%
2/339
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/670
|
0.29%
1/339
|
|
Gastrointestinal disorders
Gastritis
|
0.15%
1/670
|
0.00%
0/339
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.90%
6/670
|
0.29%
1/339
|
|
Infections and infestations
Gastroenteritis adenovirus
|
0.00%
0/670
|
0.29%
1/339
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.15%
1/670
|
0.29%
1/339
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/670
|
0.29%
1/339
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/670
|
0.29%
1/339
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.15%
1/670
|
0.00%
0/339
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/670
|
0.59%
2/339
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/670
|
0.29%
1/339
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/670
|
0.29%
1/339
|
|
Infections and infestations
Periorbital cellulitis
|
0.15%
1/670
|
0.00%
0/339
|
|
Infections and infestations
Pertussis
|
0.15%
1/670
|
0.00%
0/339
|
|
Infections and infestations
Pneumonia
|
0.60%
4/670
|
0.59%
2/339
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/670
|
0.29%
1/339
|
|
Infections and infestations
Pyelonephritis acute
|
0.30%
2/670
|
0.00%
0/339
|
|
General disorders
Pyrexia
|
0.60%
4/670
|
0.88%
3/339
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.15%
1/670
|
0.00%
0/339
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.30%
2/670
|
0.88%
3/339
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/670
|
0.29%
1/339
|
|
Infections and infestations
Sepsis
|
0.15%
1/670
|
0.00%
0/339
|
|
Infections and infestations
Urinary tract infection
|
0.15%
1/670
|
0.00%
0/339
|
Other adverse events
| Measure |
Rotarix Group
n=670 participants at risk
All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
|
Placebo Group
n=339 participants at risk
All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
9/670
|
1.5%
5/339
|
|
General disorders
Fever
|
8.1%
54/670
|
8.6%
29/339
|
|
General disorders
Irritability
|
19.9%
133/670
|
19.5%
66/339
|
|
Metabolism and nutrition disorders
Loss of appetite
|
12.1%
81/670
|
13.3%
45/339
|
|
Gastrointestinal disorders
Vomiting
|
7.8%
52/670
|
8.0%
27/339
|
|
General disorders
Pyrexia
|
4.2%
28/670
|
7.4%
25/339
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centres of a multi-centre trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER