Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 10 Weeks of Age

NCT00814710 | Completed Phase 3 Results

• 2 other identifiers: 1111882011-004644-22
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Indian infants with pneumococcal conjugate vaccine GSK1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine during the first 4 months of life. The study will be conducted in India.

Conditions

Infections, Streptococcal; Streptococcus Pneumoniae

Keywords

Pneumococcal disease; Pneumococcal vaccine; Safety; Primary vaccination; Immunogenicity

Outcome Measures

Primary Outcomes (2)

• Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes

  Concentrations were expressed as Geometric Mean Concentrations (GMCs) in microgram per milliliter (µg/mL). Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

  One month after primary immunization (month 3)

• Concentration of Antibody Against Protein D (PD)

  Concentrations were expressed as GMCs GSK's 22F-inhibition in enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

  One month after primary immunization (month 3)

Secondary Outcomes (15)

• Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes

  One month after primary immunization (month 3)

• Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value

  One month after primary immunization

• Concentrations of Antibodies Against Pneumococcal Cross-reactive Serotypes

  One month after primary immunization (month 3)

• Number of Subjects Seropositive for Pneumococcal Serotypes

  One month after primary immunization (month 3)

• Number of Subjects Seropositive for Protein D (PD)

  One month after primary immunization (month 3)

Study Arms (2)

Synflorix & Tritanrix-HebB/Hib Group

EXPERIMENTAL

Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)

Biological: Pneumococcal conjugate vaccine GSK1024850A; Biological: Tritanrix-HepB/Hib

Hiberix group & Tritanrix-HebB Group

ACTIVE COMPARATOR

Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)

Biological: Hiberix; Biological: Tritanrix-HepB

Interventions

Pneumococcal conjugate vaccine GSK1024850A BIOLOGICAL

Intramuscular injection, 3 doses

Synflorix & Tritanrix-HebB/Hib Group

Tritanrix-HepB/Hib BIOLOGICAL

Intramuscular injection, 3 doses

Also known as: DTPw-HBV/Hib

Synflorix & Tritanrix-HebB/Hib Group

Hiberix BIOLOGICAL

Intramuscular injection, 3 doses

Also known as: Hib

Hiberix group & Tritanrix-HebB Group

Tritanrix-HepB BIOLOGICAL

Intramuscular injection, 3 doses

Also known as: DTPw-HBV

Hiberix group & Tritanrix-HebB Group

Eligibility Criteria

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

You may qualify if:

• Male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination.
• Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
• Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
• Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study).

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
• 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 (pharmaceutical product or device).
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
• A family history of congenital or hereditary immunodeficiency.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (with the exception of hepatitis B immunoglobulins at birth).
• Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of hepatitis B vaccination at birth or at least 30 days before the subject's first study visit).
• History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, Streptococcus and Haemophilus influenzae type b disease.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• History of any neurological disorders or seizures.
• Major congenital defects or serious chronic illness.
• Acute disease at the time of enrolment.
• Babies for which birth weight is \< 2 kilogram.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (4)

GSK Investigational Site

Kolkata, 700073, India

Location

GSK Investigational Site

Ludhiana, 141 008, India

Location

GSK Investigational Site

Pune, India

Location

GSK Investigational Site

Vellore, 632004, India

Location

Related Publications (2)

• Lalwani S, Chatterjee S, Chhatwal J, Verghese VP, Mehta S, Shafi F, Borys D, Moreira M, Schuerman L. Immunogenicity, safety, and reactogenicity of the 10-valent pneumococcal non-typeable Hemophilus influenzae protein D conjugate vaccine (PHiD-CV) when co-administered with the DTPw-HBV/Hib vaccine in Indian infants: a single-blind, randomized, controlled study. Hum Vaccin Immunother. 2012 May;8(5):612-22. doi: 10.4161/hv.19287. Epub 2012 May 1.

  PMID: 22634448 BACKGROUND

• Lalwani S, Chatterjee S, Chhatwal J, Simon A, Ravula S, Francois N, Mehta S, Strezova A, Borys D. Randomized, open-label study of the impact of age on booster responses to the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in children in India. Clin Vaccine Immunol. 2014 Sep;21(9):1292-300. doi: 10.1128/CVI.00068-14. Epub 2014 Jul 9.

  PMID: 25008901 DERIVED

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

Streptococcal Infections; Pneumococcal Infections

Interventions

Hiberix; Tritanrix-HepB vaccine

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

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: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2008
• First Posted: December 25, 2008
• Study Start: March 7, 2009
• Primary Completion: November 13, 2009
• Study Completion: November 13, 2009
• Last Updated: January 3, 2020
• Results First Posted: October 29, 2010

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)