Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine

NCT ID: NCT01353703

Last Updated: 2020-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-16
• Study Completion Date: 2013-02-25

Brief Summary

This study evaluates the immunogenicity and safety of Infanrix hexa™ (DTPa-HBV-IPV/Hib) when administered as a primary vaccination course to Indian infants according to a 6-10-14 weeks or a 2-4-6 months schedule.

Conditions

Poliomyelitis; Tetanus; Acellular Pertussis; Haemophilus Influenzae Type b; Diphtheria; Hepatitis B; Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

INFANRIX HEXA 6-10-14 GROUP

Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.

Group Type: EXPERIMENTAL

Infanrix hexa™

Intervention Type: BIOLOGICAL

Intramuscular, three doses

INFANRIX HEXA 2-4-6 GROUP

Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.

Group Type: ACTIVE_COMPARATOR

Infanrix hexa™

Intervention Type: BIOLOGICAL

Intramuscular, three doses

Interventions

Infanrix hexa™

Intramuscular, three doses

Intervention Type: BIOLOGICAL

Other Intervention Names

DTPa-HBV-IPV/Hib

Eligibility Criteria

Inclusion Criteria

All subjects must satisfy ALL the following criteria at study entry:

• A male or female between, and including, 6 and 10 weeks of age at the time of the first vaccination
• Documented administration of a hepatitis B vaccine dose at birth
• Subjects who the investigator believes that their parent(s)/legally acceptable representative(s) [LAR(s)] can and will comply with the requirements of the protocol
• Written informed consent obtained from the parent(s)/LAR(s) of the subject
• Healthy subjects as established by medical history and clinical examination before entering into the study
• Born after a gestation period of at least 36 weeks

Exclusion Criteria

The following criteria should be checked at the time of study entry. If ANYexclusion criterion applies, the subject must not be included in the study:

• Child in care
• Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose, or planned use during the study period
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose
• Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period, with the exception of oral human rotavirus (HRV) vaccination which is allowed at any time during the study
• 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
• Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b (Hib) vaccination or disease, with the exception of a birth dose of hepatitis B vaccine and oral poliovirus vaccine (OPV) as per local standard of care
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
• Family history of congenital or hereditary immunodeficiency
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
• Major congenital defects or serious chronic illness
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
• Acute disease and/or fever at the time of enrolment

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 10 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Belgaun, , India

GSK Investigational Site

Chennai, , India

GSK Investigational Site

Pune, , India

GSK Investigational Site

Pune, , India

Countries

India

References

Lalwani SK, Agarkhedkar S, Sundaram B, Mahantashetti NS, Malshe N, Agarkhedkar S, Van Der Meeren O, Mehta S, Karkada N, Han HH, Mesaros N. Immunogenicity and safety of 3-dose primary vaccination with combined DTPa-HBV-IPV/Hib in Indian infants. Hum Vaccin Immunother. 2017 Jan 2;13(1):120-127. doi: 10.1080/21645515.2016.1225639. Epub 2016 Sep 15.

Reference Type: BACKGROUND

PMID: 27629913 (View on PubMed)

Study Documents

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

2013-003427-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

111157

Identifier Type: -

Identifier Source: org_study_id