Trial Outcomes & Findings for Immunogenicity, Reactogenicity and Safety Study of Two Different Formulations of GSK Biologicals' Human Rotavirus Vaccine, Rotarix, in Healthy Infants (NCT NCT02141204)

NCT ID: NCT02141204

Last Updated: 2020-12-09

Results Overview

Serum anti-RV IgA antibody concentrations were expressed as geometric mean concentrations (GMCs).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

451 participants

Primary outcome timeframe

At Month 2

Results posted on

2020-12-09

Participant Flow

The study was conducted at 8 centers in India.

Out of 451 subjects enrolled in the study, 1 subject did not receive any study treatment and 1 vaccinated subject was eliminated from all analysis due to incorrect impartial witness. 449 subjects were vaccinated and included in the Exposed Set, 419 subjects completed the study.

Participant milestones

Participant milestones
Measure	HRV Liq Group Subjects aged 6 to 10 weeks at the time of first vaccination, who received two oral doses of Liquid Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.	HRV Lyo Group Subjects aged 6 to 10 weeks at the time of first vaccination who received two oral doses of Lyophilized Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.
Overall Study STARTED	224	225
Overall Study COMPLETED	209	210
Overall Study NOT COMPLETED	15	15

Reasons for withdrawal

Reasons for withdrawal
Measure	HRV Liq Group Subjects aged 6 to 10 weeks at the time of first vaccination, who received two oral doses of Liquid Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.	HRV Lyo Group Subjects aged 6 to 10 weeks at the time of first vaccination who received two oral doses of Lyophilized Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.
Overall Study Lost to Follow-up	2	1
Overall Study CONSENT WITHDRAWAL NOT DUE TO AE	1	2
Overall Study MIGRATED / MOVED FROM THE STUDY AREA	3	5
Overall Study NOT WILLING TO PARTICIPATE THIS VISIT	9	7

Baseline Characteristics

Immunogenicity, Reactogenicity and Safety Study of Two Different Formulations of GSK Biologicals' Human Rotavirus Vaccine, Rotarix, in Healthy Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HRV Liq Group n=224 Participants Subjects aged 6 to 10 weeks at the time of first vaccination, who received two oral doses of Liquid Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.	HRV Lyo Group n=225 Participants Subjects aged 6 to 10 weeks at the time of first vaccination who received two oral doses of Lyophilized Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.	Total n=449 Participants Total of all reporting groups
Age, Continuous	6.8 Weeks STANDARD_DEVIATION 1.0 • n=5 Participants	6.8 Weeks STANDARD_DEVIATION 1.1 • n=7 Participants	6.8 Weeks STANDARD_DEVIATION 1.0 • n=5 Participants
Sex: Female, Male Female	100 Participants n=5 Participants	120 Participants n=7 Participants	220 Participants n=5 Participants
Sex: Female, Male Male	124 Participants n=5 Participants	105 Participants n=7 Participants	229 Participants n=5 Participants
Race/Ethnicity, Customized Asian	224 Participants n=5 Participants	225 Participants n=7 Participants	449 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Month 2

Population: Analysis was performed on Per Protocol Set (PPS) for immunogenicity, which included all eligible subjects who received both doses of HRV vaccine, complied with vaccination schedule and for whom immunogenicity data were available at the specified time point.

Serum anti-RV IgA antibody concentrations were expressed as geometric mean concentrations (GMCs).

Outcome measures

Outcome measures
Measure	HRV Liq Group n=189 Participants Subjects aged 6 to 10 weeks at the time of first vaccination, who received two oral doses of Liquid Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.	HRV Lyo Group n=192 Participants Subjects aged 6 to 10 weeks at the time of first vaccination who received two oral doses of Lyophilized Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.
Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations	90.25 U/mL Interval 67.28 to 121.06	94.16 U/mL Interval 70.29 to 126.13

SECONDARY outcome

Timeframe: At Month 2

Population: Analysis was performed on PPS for immunogenicity, which included all eligible subjects who received both doses of HRV vaccine, complied with vaccination schedule and for whom immunogenicity data were available at the specified time point.

Seroconversion is defined as: - for subjects with a pre-vaccination anti-RV IgA antibody concentration lower than (\<) 20 U/mL, seroconversion is achieved when the post-vaccination concentration is greater than or equal to (≥) 20 U/mL and \- for subjects with a pre-vaccination anti-RV IgA antibody concentration ≥ 20 U/mL, seroconversion is achieved when the post-vaccination concentration is ≥ 2 times the pre-vaccination concentration.

Outcome measures

Outcome measures
Measure	HRV Liq Group n=189 Participants Subjects aged 6 to 10 weeks at the time of first vaccination, who received two oral doses of Liquid Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.	HRV Lyo Group n=192 Participants Subjects aged 6 to 10 weeks at the time of first vaccination who received two oral doses of Lyophilized Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.
Percentage of Seroconverted Subjects for Anti-RV IgA Antibodies	54.5 Percentage of subjects Interval 47.1 to 61.7	50.0 Percentage of subjects Interval 42.7 to 57.3

SECONDARY outcome

Timeframe: During the 8-day follow-up period after each vaccination (vaccines administered at Day 1 and Month 1)

Population: Analysis was performed on the Exposed Set (ES), which included all subjects with at least one study vaccine administration documented and with the diary card completed.

Solicited general AEs assessed were fever (defined as temperature ≥ 38.0°C/100.4°F, the preferred location for measuring temperature in this study being the oral cavity, the axilla and the rectum), irritability/fussiness, diarrhea (defined as passage of three or more looser than normal stools within a day), vomiting (defined as one or more episodes of forceful emptying of partially digested stomach contents ≥1 hour after feeding within a day), loss of appetite and cough/runny nose. Any = occurrence of AE regardless of intensity grade or relation to study vaccination.

Outcome measures

Outcome measures
Measure	HRV Liq Group n=224 Participants Subjects aged 6 to 10 weeks at the time of first vaccination, who received two oral doses of Liquid Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.	HRV Lyo Group n=225 Participants Subjects aged 6 to 10 weeks at the time of first vaccination who received two oral doses of Lyophilized Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.
Number of Subjects With Any Solicited General Adverse Events (AEs) Cough/Runny Nose (Dose 1), Any	22 Participants	24 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) Cough/Runny Nose (Dose 2), Any	17 Participants	23 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) Diarrhea (Dose 1), Any	4 Participants	2 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) Diarrhea (Dose 2), Any	3 Participants	3 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) Fever (Dose 1), ≥ 38.0°C	57 Participants	48 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) Fever (Dose 2), ≥ 38.0°C	50 Participants	53 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) Irritability/Fussiness (Dose 1), Any	71 Participants	83 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) Irritability/Fussiness (Dose 2), Any	56 Participants	61 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) Loss of appetite (Dose 1), Any	33 Participants	42 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) Loss of appetite (Dose 2), Any	28 Participants	25 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) Vomiting (Dose 1), Any	22 Participants	22 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) Vomiting (Dose 2), Any	15 Participants	13 Participants

SECONDARY outcome

Timeframe: During the 31-day follow-up period across doses (vaccines administered at Day 1 and Month 1)

Population: Analysis was performed on the ES, which included all subjects with at least one study vaccine administration documented.

An unsolicited AE is defined as 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, and reported in addition to those solicited during the clinical study and any 'solicited' AE with onset outside the specified period of follow-up for solicited AE. Any = occurrence of AE regardless of intensity grade or relation to study vaccination.

Outcome measures

Outcome measures
Measure	HRV Liq Group n=224 Participants Subjects aged 6 to 10 weeks at the time of first vaccination, who received two oral doses of Liquid Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.	HRV Lyo Group n=225 Participants Subjects aged 6 to 10 weeks at the time of first vaccination who received two oral doses of Lyophilized Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.
Number of Subjects With Any Unsolicited AEs	54 Participants	58 Participants

SECONDARY outcome

Timeframe: Throughout the study period (from Day 1 up to Month 2)

Population: Analysis was performed on the ES, which included all subjects with at least one study vaccine administration documented.

SAEs assessed included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization and/or resulted in disability/incapacity. Any = occurrence of SAE regardless of intensity grade or relation to study vaccination.

Outcome measures

Outcome measures
Measure	HRV Liq Group n=224 Participants Subjects aged 6 to 10 weeks at the time of first vaccination, who received two oral doses of Liquid Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.	HRV Lyo Group n=225 Participants Subjects aged 6 to 10 weeks at the time of first vaccination who received two oral doses of Lyophilized Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.
Number of Subjects With Any Serious Adverse Events (SAEs)	7 Participants	2 Participants

Adverse Events

HRV Liq Group

Serious events: 7 serious events

Other events: 146 other events

Deaths: 0 deaths

HRV Lyo Group

Serious events: 2 serious events

Other events: 162 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	HRV Liq Group n=224 participants at risk Subjects aged 6 to 10 weeks at the time of first vaccination, who received two oral doses of Liquid Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.	HRV Lyo Group n=225 participants at risk Subjects aged 6 to 10 weeks at the time of first vaccination who received two oral doses of Lyophilized Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.
Infections and infestations Bronchiolitis	1.3% 3/224 • Number of events 3 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (Day 1 to Month 2)	0.00% 0/225 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (Day 1 to Month 2)
Infections and infestations Dengue fever	0.00% 0/224 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (Day 1 to Month 2)	0.44% 1/225 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (Day 1 to Month 2)
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/224 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (Day 1 to Month 2)	0.44% 1/225 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (Day 1 to Month 2)
Infections and infestations Gastroenteritis	0.89% 2/224 • Number of events 2 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (Day 1 to Month 2)	0.00% 0/225 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (Day 1 to Month 2)
Gastrointestinal disorders Intestinal obstruction	0.45% 1/224 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (Day 1 to Month 2)	0.00% 0/225 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (Day 1 to Month 2)
Infections and infestations Pneumonia	0.45% 1/224 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (Day 1 to Month 2)	0.00% 0/225 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (Day 1 to Month 2)
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.45% 1/224 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (Day 1 to Month 2)	0.00% 0/225 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (Day 1 to Month 2)
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/224 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (Day 1 to Month 2)	0.44% 1/225 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (Day 1 to Month 2)
Infections and infestations Urinary tract infection	0.45% 1/224 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (Day 1 to Month 2)	0.00% 0/225 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (Day 1 to Month 2)

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

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 centers of a multi-center 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