Study to Assess the Efficacy, Immunogenicity and Safety of Liquid Human Rotavirus Vaccine, in Healthy Chinese Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01171963
First received: July 28, 2010
Last updated: December 19, 2013
Last verified: October 2013
Results First Received: May 2, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Infections, Rotavirus
Interventions: Biological: GSK Biologicals' liquid human rotavirus vaccine 444563
Biological: Placebo
Biological: Infanrix™
Biological: Institute of Medical Biology Chinese Academy of Medical Sciences' Oral poliovirus vaccine (OPV)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Duration of the study was of a maximum of 21 months, with the enrolment of subjects starting in August 2010, and subjects being followed up to May 2012 (study Month 21 and Study End), end of the rotavirus season in China.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were assigned to 2 sub-cohorts (1:1 ratio). Sub-cohort 1 and Sub-cohort 2 subjects received their OPV and Infanrix™ EPI vaccination respectively independently of, and concomitantly with their Rotarix™/placebo vaccination. 3340 subjects were allocated study subject number allocated and 3333 vaccinated .

Reporting Groups
  Description
Rotarix Group Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
Placebo Group Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.

Participant Flow:   Overall Study
    Rotarix Group     Placebo Group  
STARTED     1666     1667  
COMPLETED     1518     1499  
NOT COMPLETED     148     168  
Adverse Event                 10                 15  
Lost to Follow-up                 23                 24  
Other - diarrhoea                 1                 0  
Withdrawal by Subject                 114                 129  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Rotarix Group Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
Placebo Group Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
Total Total of all reporting groups

Baseline Measures
    Rotarix Group     Placebo Group     Total  
Number of Participants  
[units: participants]
  1666     1667     3333  
Age  
[units: Weeks]
Mean ± Standard Deviation
  9.5  ± 2.64     9.7  ± 2.59     9.6  ± 2.62  
Gender  
[units: subjects]
     
Female     795     836     1631  
Male     871     831     1702  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains   [ Time Frame: From Month 1 ½ to Month 21 ]

2.  Secondary:   Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild-type Strains   [ Time Frame: From Month 1 ½ to Month 21 ]

3.  Secondary:   Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type.   [ Time Frame: From Month 1 ½ to Month 21 ]

4.  Secondary:   Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type.   [ Time Frame: From Month 1 ½ to Month 21 ]

5.  Secondary:   Number of Subjects With Episodes of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains Requiring Hospitalization   [ Time Frame: From Month 1 ½ to Month 21 ]

6.  Secondary:   Number of Subjects With Any and Severe Gastroenteritis (GE) Due to Any Cause   [ Time Frame: From Month 1 ½ to Month 21 ]

7.  Secondary:   Number of Subjects With Any Solicited General Symptoms Following Vaccination With the Rotarix™ Vaccine/Placebo   [ Time Frame: Within the 8-day (Days 0–7) follow-up periods after any dose of Rotarix™ vaccine/placebo ]

8.  Secondary:   Number of Subjects With Any Solicited General Symptoms Following Administration of the Co-administered EPI Vaccines   [ Time Frame: Within the 8-day (Days 0–7) follow-up periods following Doses 1 and 2 of the OPV vaccine and Dose 1 of the Infanrix™ vaccine ]

9.  Secondary:   Number of Subjects With Any Solicited Local Symptoms Following Dose 2 of the Rotarix™ Vaccine/Placebo   [ Time Frame: Within the 8-day (Days 0–7) follow-up periods following Dose 2 of the Rotarix™ vaccine/placebo ]

10.  Secondary:   Number of Subjects With Any Unsolicited Adverse Events (AEs)   [ Time Frame: Within the 31-day (Days 0–30) follow-up periods following any dose of the Rotarix™ vaccine or placebo ]

11.  Secondary:   Number of Subjects With Any Serious Adverse Events (SAEs)   [ Time Frame: Throughout the entire study period (from Day 0 to Study End at Month 21) ]

12.  Secondary:   Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies   [ Time Frame: At Month 2 and at 12 months of age ]

13.  Secondary:   Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.   [ Time Frame: At Month 2 and at 12 months of age ]

14.  Secondary:   Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.   [ Time Frame: At Month 2 and at 12 months of age ]

15.  Secondary:   Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.   [ Time Frame: At Day 0, Month 2 and at 12 months of age ]

16.  Secondary:   Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.   [ Time Frame: At Day 0, Month 2 and at 12 months of age ]

17.  Secondary:   Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.   [ Time Frame: At Day 0, Month 2 and at 12 months of age ]

18.  Secondary:   Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations   [ Time Frame: At Day 0, Month 2 and at 12 months of age ]

19.  Secondary:   Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations.   [ Time Frame: At Day 0, Month 2 and at 12 months of age. ]

20.  Secondary:   Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations.   [ Time Frame: At Day 0, Month 2 and at 12 months of age ]

21.  Secondary:   Number of Subjects Seroprotected Against Diphtheria and Tetanus   [ Time Frame: At Day 0 and at Month 4 ]

22.  Secondary:   Anti-Diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations   [ Time Frame: At Day 0 and at Month 4 ]

23.  Secondary:   Number of Subjects Seroprotected Against Poliovirus Types 1, 2 and 3.   [ Time Frame: At Day 0 and at Month 4 ]

24.  Secondary:   Titers for Anti-poliovirus Type 1 (Anti-polio 1), Anti-polio 2 and Anti-polio 3 Antibodies   [ Time Frame: At Day 0 and at Month 4 ]

25.  Secondary:   Number of Subjects Seropositive for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies.   [ Time Frame: At Day 0 and at Month 4 ]

26.  Secondary:   Concentrations for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin   [ Time Frame: At Day 0 and at Month 4 ]


  Serious Adverse Events


  Other Adverse Events


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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01171963     History of Changes
Other Study ID Numbers: 113808
Study First Received: July 28, 2010
Results First Received: May 2, 2013
Last Updated: December 19, 2013
Health Authority: China: Food and Drug Administration