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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NCT03128489 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2017-12-26

No results posted yet for this study

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

Interventions

BIOLOGICAL

Infanrix-IPV/Hib

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Weeks
Max Age
9 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2018-08-01
Completion
2018-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03128489 on ClinicalTrials.gov