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

Purpose

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.

Condition	Intervention	Phase
Poliomyelitis Tetanus Acellular Pertussis Haemophilus Influenzae Type b Diphtheria Hepatitis B	Biological: Infanrix hexa™	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Infanrix Hexa™ Vaccine in Healthy Infants in India

Resource links provided by NLM:

MedlinePlus related topics: Haemophilus Infections Tetanus, Diphtheria, and Pertussis Vaccines

Drug Information available for: Boostrix

Genetic and Rare Diseases Information Center resources: Whooping Cough Tetanus Diphtheria Haemophilus Influenzae Poliomyelitis Myelitis

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Immunogenicity with respect to components of the study vaccine, in terms of number of seroprotected subjects [ Time Frame: One month after the third dose of primary vaccination, i.e. at the age of 18 weeks or 7 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Immunogenicity with respect to components of the study vaccine in terms of antibody titres [ Time Frame: Before the first dose of primary vaccination (Day 0) and one month after the third dose of primary vaccination, i.e. at the age of 18 weeks or 7 months ] [ Designated as safety issue: No ]
Occurrence of solicited local and general symptoms [ Time Frame: During the 4-day (Day 0-Day 3) follow-up period after each vaccination ] [ Designated as safety issue: No ]
Occurrence of unsolicited adverse events [ Time Frame: During the 31-day (Day 0-Day 30) follow-up period after each vaccination ] [ Designated as safety issue: No ]
Occurrence of serious adverse events [ Time Frame: From Dose 1 (Day 0) up to study end i.e. at the age of 18 weeks or 7 months ] [ Designated as safety issue: No ]


Enrollment:	214
Study Start Date:	April 2012
Study Completion Date:	February 2013
Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group A Subjects will receive Infanrix hexa™ at 6, 10 and 14 weeks of age	Biological: Infanrix hexa™ Intramuscular, three doses Other Name: DTPa-HBV-IPV/Hib
Active Comparator: Group B Subjects will receive Infanrix hexa™ at 2, 4 and 6 months of age	Biological: Infanrix hexa™ Intramuscular, three doses Other Name: DTPa-HBV-IPV/Hib

Eligibility


Ages Eligible for Study:	6 Weeks to 10 Weeks (Child)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01353703

Locations


India
GSK Investigational Site
Belgaun, India, 590010
GSK Investigational Site
Chennai, India
GSK Investigational Site
Pune, India, 411018
GSK Investigational Site
Pune, India

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information


Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01353703 History of Changes
Other Study ID Numbers:	111157
Study First Received:	May 12, 2011
Last Updated:	July 10, 2014
Health Authority:	India: Drugs Controller General of India

Keywords provided by GlaxoSmithKline:


Infanrix hexa™ Primary vaccination India combination vaccine infants

Additional relevant MeSH terms:


Hepatitis B Diphtheria Poliomyelitis Hepadnaviridae Infections DNA Virus Infections Virus Diseases Hepatitis, Viral, Human Hepatitis Liver Diseases Digestive System Diseases Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections	Bacterial Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections Myelitis Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Neuromuscular Diseases Vaccines Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 28, 2016