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

Study Description

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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.

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	214 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Infanrix Hexa™ Vaccine in Healthy Infants in India
Study Start Date :	April 2012
Actual Primary Completion Date :	February 2013
Actual Study Completion Date :	February 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. 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 ]
2. Occurrence of solicited local and general symptoms [ Time Frame: During the 4-day (Day 0-Day 3) follow-up period after each vaccination ]
3. Occurrence of unsolicited adverse events [ Time Frame: During the 31-day (Day 0-Day 30) follow-up period after each vaccination ]
4. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	6 Weeks to 10 Weeks (Child)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01353703 History of Changes
Other Study ID Numbers:	111157
First Posted:	May 16, 2011
Last Update Posted:	July 14, 2014
Last Verified:	April 2013

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