Evaluation of Immunogenicity and Safety of DTPa-IPV/Hib Conjugate Vaccine (Infanrix™-IPV/Hib) Administered at 6, 10 and 14 Weeks in Healthy Indian Infants

NCT03128489 | Withdrawn Phase 3

• 2 other identifiers: 2011242013-004361-14
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the immunogenicity and safety of DTPa-IPV/Hib when administered at 6, 10 and 14 weeks to healthy Indian infants, as per guidance from the Indian regulatory authority. The 6, 10 and 14 week schedule reflects the current Indian standard of care.

Conditions

Diphtheria; Acellular Pertussis; Haemophilus Influenzae Type b; Tetanus; Poliomyelitis

Keywords

Safety; Infanrix™-IPV/Hib; Immunogenicity; Indian infants; Combined vaccine

Outcome Measures

Primary Outcomes (4)

• Number of seroprotected subjects in terms of anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies.

  A seroprotected subject is a subject whose anti-D/anti-T antibody concentration is greater than or equal to (≥) 0.1 International Units per millilitre (IU/ml).

  One month after the third dose of primary vaccination (Month 3)

• Number of seroprotected subjects in terms of anti-poliomyelitis (anti-Polio) types 1, 2 and 3 antibodies.

  A seroprotected subject is a subject whose anti-Polio 1, 2 and 3 antibody titers are greater than or equal to (≥) 8 median effective dose (ED50).

  One month after the third dose of primary vaccination (Month 3)

• Number of seroprotected subjects in terms of anti-polysaccharide Polyribosyl-Ribitol Phosphate (anti-PRP) antibodies.

  A seroprotected subject is a subject whose anti-PRP antibody concentration is greater than or equal to (≥) 0.15 micrograms per millilitre (µg/ml).

  One month after the third dose of primary vaccination (Month 3)

• Number of subjects with vaccine response to pertussis toxoid (PT), Filamentous Haemagglutinin (FHA) and pertactin (PRN) antigens.

  Vaccine response to pertussis antigens is defined as the appearance of antibodies in subjects who were initially seronegative (i.e., with concentrations lesser than the assay cut-off value), or maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e., with concentrations ≥ assay cut-off value).

  One month after the third dose of primary vaccination (Month 3)

Secondary Outcomes (15)

• Anti-D and anti-T antibody concentrations.

  One month after the third dose of primary vaccination (Month 3).

• Anti-Polio type 1, 2 and 3 antibody titres.

  One month after the third dose of primary vaccination (Month 3)

• Anti-PRP antibody concentrations.

  One month after the third dose of primary vaccination (Month 3).

• Anti-PT, anti-FHA and anti-PRN antibody concentrations.

  One month after the third dose of primary vaccination (Month 3)

• Number of seropositive subjects in terms of anti-PT, anti-FHA and anti-PRN antibodies.

  One month after the third dose of primary vaccination (Month 3).

Study Arms (1)

DTPa-IPV/Hib Group

EXPERIMENTAL

All subjects will receive three doses of primary vaccination at 6, 10 and 14 weeks of age.

Biological: Infanrix-IPV/Hib

Interventions

Infanrix-IPV/Hib BIOLOGICAL

Subjects will receive (Infanrix-IPV/Hib) as three-dose primary vaccination course at 6, 10 and 14 weeks of age. The vaccine will be administered intramuscularly, at a 90-degree angle into the anterolateral side of the thigh on the right side. The vaccine should not be administered in the buttock.

DTPa-IPV/Hib Group

Eligibility Criteria

• Age: 6 Weeks - 9 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects' parent(s)/Legally Acceptable Representatives \[LARs\] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• A male or female between, and including, 6 and 9 weeks of age (42-69 days) at the time of the first vaccination.
• Written informed consent obtained from the parents/LARs of the subject prior to performing any study specific procedure.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Born full-term \[i.e., after a gestation period of 37 to less than 42 completed weeks (259 to 293 days)\].

You may not qualify if:

• Child in care.
• Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before first dose of study vaccine (Day-29 to Day 0), or planned use during the study period.
• Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
• Chronic administration of immunosuppressants or other immune-modifying drugs from birth to within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone (0.5 mg/kg/day, or equivalent). Inhaled and topical steroids are allowed.
• Administration of long-acting immune-modifying drugs at any time during the study period.
• Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and 30 days after the last dose of vaccine with the exception of human rotavirus vaccine, hepatitis B vaccine, pneumococcal conjugate vaccine and other vaccines given as a part of the national immunisation schedule, that are allowed at any time 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 vaccine/product.
• History of diphtheria, tetanus, pertussis, poliomyelitis and Hib disease.
• Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Hib vaccination or disease prior to study enrolment, with the exception of a birth dose of hepatitis B and/or Baccillus Calmette-Guerin (BCG) vaccines and/or oral poliovirus (OPV) vaccine as per local standard of care. The BCG vaccination should occur at least 30 days prior to first dose of vaccination in the study.
• 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.
• History of any neurological disorders or seizures.
• Acute disease and/or fever at the time of enrolment.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Diphtheria; Haemophilus Infections; Tetanus; Poliomyelitis

Interventions

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

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pasteurellaceae Infections; Gram-Negative Bacterial Infections; Clostridium Infections; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: April 25, 2017
• Study Start: December 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: December 26, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will share