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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01353703
First received: May 12, 2011
Last updated: April 18, 2013
Last verified: April 2013
History of Changes
  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
Diphtheria
Hepatitis B
Haemophilus Influenzae Type b Disease
Poliomyelitis
Pertussis
Tetanus
 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:

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
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
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
GSK Investigational Site
Pune, India, 411018
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01353703     History of Changes
Other Study ID Numbers: 111157
Study First Received: May 12, 2011
Last Updated: April 18, 2013
Health Authority: India: Drugs Controller General of India

Keywords provided by GlaxoSmithKline:
Infanrix hexa™
Primary vaccination
India
combination vaccine
infants

Additional relevant MeSH terms:
Diphtheria
Hepatitis
Hepatitis A
Hepatitis B
Influenza, Human
Whooping Cough
Poliomyelitis
Tetanus
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Orthomyxoviridae Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Infection
Myelitis
Central Nervous System Viral Diseases
Central Nervous System Infections

ClinicalTrials.gov processed this record on May 23, 2013