Immunogenicity and Safety Study of GSK Biologicals' Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants

GlaxoSmithKline1 site in 1 country585 target enrollmentApril 16, 2014

ConditionsPoliomyelitis Diphtheria Haemophilus Influenzae Type b Tetanus Acellular Pertussis Hepatitis B

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Poliomyelitis
Sponsor: GlaxoSmithKline
Enrollment: 585
Locations: 1
Primary Endpoint: Antibody Concentrations for Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN).
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' Infanrix hexa vaccine when administered to healthy infants as primary vaccination at 2, 4 and 6 months of age, co-administered with Prevnar and Rotarix with a booster dose of GSK Biologicals' Infanrix and Hiberix vaccines at 15-18 months of age.

Registry

clinicaltrials.gov

Start Date

April 16, 2014

End Date

November 13, 2015

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects' parent(s)/ Legally Acceptable Representative(s) (LARs) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
•A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
•Born full-term (i.e. after a gestation period of 37 weeks to less than 42 completed weeks \[259 to 293 days\]).
•Written informed consent obtained from parent(s)/LAR(s) of the subject.
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrolment.

Exclusion Criteria

•Child in care
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period.
•Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
•Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting from 30 days before the first vaccination until 30 days after Dose 3 (Epoch 001, primary vaccination) and from 30 days before the booster Dose 4 until 30 days after booster Dose 4 (Epoch 002, booster vaccination), i.e. the end of the study:
•Inactivated influenza and hepatitis A vaccines are allowed throughout the study.
•Routine administration(s) of vaccines are allowed from 30 days after the last dose of primary vaccination until 30 days before the booster dose and after post-booster blood sampling. Routine administration of measles-mumps-rubella vaccine, varicella, pneumococcal vaccines are allowed from 30 days after last dose of primary vaccine until 30 days before booster dose and from post-booster blood sampling, as well as according to the recommended immunization schedule in US.
•Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
•History of Hib, diphtheria, tetanus, pertussis, pneumococcal, rotavirus, poliovirus and hepatitis B diseases.
•Previous vaccination against Hib, diphtheria, tetanus, pertussis, pneumococcus, rotavirus and/or poliovirus; more than one previous dose of hepatitis B vaccine.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).

Outcomes

Primary Outcomes

Antibody Concentrations for Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN).

Time Frame: At Month 5, one month after the third dose of the primary vaccination.

Concentrations were expressed as geometric mean concentrations (GMCs) for the following cut-offs:2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN. The results for the Infanrix hexa Group and Pediarix Group were the primary outcome variables.

Secondary Outcomes

Number of Seroprotected Subjects Against Tetanus (T).(At Month 5, one month after the third dose of the primary vaccination.)
Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3.(At Visit 5 [At Month 13-16 before the booster dose (Dose 4)])
Antibody Concentrations for Anti-T.(At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)])
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL.(At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose4)])
Antibody Concentrations for Anti-HBs.(At Visit 5 [At Month 13-16 before the booster dose (Dose 4)])
Number of Subjects With Specific Adverse Events (AEs).(From Month 0 up to 6 months post primary-vaccination (Month 10))
Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN.(At Visit 5 [Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [Month 14-17 one month after the booster dose (Dose 4)])
Number of Subjects With Specific AEs.(During the 31-day (Days 0-30) post-booster vaccination.)
Number of Seroprotected Subjects Against Diphtheria (D).(At Month 5, one month after the third dose of the primary vaccination.)
Number of Seroprotected Subjects Against Polyribosyl Ribitol Phosphate (Anti-PRP).(At Month 5, one month after the third dose of the primary vaccination)
Number of Subjects With Solicited Local Symptoms.(During the 4-day (Days 0-3) post-booster vaccination.)
Number of Subjects With Unsolicited AEs.(During the 31-day (Days 0-30) post-booster vaccination.)
Number of Subjects With a Booster Response for Anti-PT, Anti-FHA and Anti-PRN.(At Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)])
Number of Seroprotected Subjects Against Anti-PRP.(At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose4)])
Antibody Titres for Anti-polio Types 1, 2 and 3.(At Visit 5 [At Month 13-16 before the booster dose (Dose 4)])
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.(At Visit 5 [Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [Month 14-17 one month after the booster dose (Dose 4)])
Antibody Concentrations for Anti-D.(At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)])
Antibody Concentrations for Anti-PRP.(At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)])
Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs).(At Month 5, one month after the third dose of the primary vaccination)
Number of Subjects With Serious Adverse Events (SAEs).(From Month 0 up to 6 months post-primary vaccination (Month 10))
Number of Seroprotected Subjects Against Anti-D.(At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 (At Month 14-17 one month after the booster dose (Dose 4)])
Number of Subjects With Solicited General Symptoms.(During the 4-day (Days 0-3) post-booster vaccination.)
Number of Seroprotected Subjects Against Anti-T.(At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 (At Month 14-17 one month after the booster dose (Dose 4)])
Number of Seroprotected Subjects Against Anti-HBs.(At Visit 5 [At Month 13-16 before the booster dose (Dose 4)])
Number of Subjects With SAEs.(During the 31-day (Days 0-30) post-booster vaccination.)