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

NCT01353703 | Completed Phase 3 Results

• 2 other identifiers: 1111572013-003427-10
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 4

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

Keywords

Infanrix hexa™; Primary vaccination; India; combination vaccine; infants

Outcome Measures

Primary Outcomes (5)

• Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens

  A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).

  One month post Dose 3 (Month 3 or Month 5)

• Number of Seroprotected Subjects Against Hepatitis B (HBs)

  A seroprotected subject was defined as a vaccinated subject with anti-HBS antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).

  One month post Dose 3 (Month 3 or Month 5)

• Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens

  A seroprotected subject was defined as a subject with anti-Poliovirus 1,2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50).

  One month post Dose 3 (Month 3 or Month 5)

• Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) Antigens

  A seroprotected subject was defined as a subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).

  One month post Dose 3 (Month 3 or Month 5)

• Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)

  Vaccine response was defined as : For initially seronegative subjects (S-), antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at 1 month after the third dose; For initially seropositive subjects (S+): antibody concentration at 1 month after the third dose ≥ 1 fold increase in the pre-vaccination antibody concentration.

  One month post Dose 3 (Month 3 or Month 5)

Secondary Outcomes (16)

• Anti-D and Anti-T Antibody Concentrations

  One month post Dose 3 (Month 3 or Month 5)

• Anti-HBs Antibody Concentrations

  One month post Dose 3 (Month 3 or Month 5)

• Anti-Polio Types 1, 2, 3 Antibody Titers

  One month post Dose 3 (Month 3 or Month 5)

• Anti-PRP Antibody Concentrations

  One month post Dose 3 (Month 3 or Month 5)

• Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations

  One month post Dose 3 (Month 3 or Month 5)

Study Arms (2)

INFANRIX HEXA 6-10-14 GROUP

EXPERIMENTAL

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.

Biological: Infanrix hexa™

INFANRIX HEXA 2-4-6 GROUP

ACTIVE COMPARATOR

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.

Biological: Infanrix hexa™

Interventions

Infanrix hexa™ BIOLOGICAL

Intramuscular, three doses

Also known as: DTPa-HBV-IPV/Hib

INFANRIX HEXA 2-4-6 GROUP; INFANRIX HEXA 6-10-14 GROUP

Eligibility Criteria

• Age: 6 Weeks - 10 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (4)

GSK Investigational Site

Belgaun, 590010, India

Location

GSK Investigational Site

Chennai, India

Location

GSK Investigational Site

Pune, 411018, India

Location

GSK Investigational Site

Pune, India

Location

Related Publications (1)

• 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.

  PMID: 27629913 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Poliomyelitis; Tetanus; Haemophilus Infections; Diphtheria; Hepatitis B

Interventions

diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Pasteurellaceae Infections; Gram-Negative Bacterial Infections; Corynebacterium Infections; Actinomycetales Infections; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2011
• First Posted: May 16, 2011
• Study Start: April 16, 2012
• Primary Completion: February 25, 2013
• Study Completion: February 25, 2013
• Last Updated: January 2, 2020
• Results First Posted: January 25, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

IN (4)