Trials / Withdrawn
WithdrawnNCT03128489
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
Immunogenicity and Safety of GSK Biologicals' DTPa-IPV/Hib Conjugate Vaccine (Infanrix™-IPV/Hib) (SB213503) in Healthy Indian Infants
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 6 Weeks – 9 Weeks
- Healthy volunteers
- Accepted
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.
Detailed description
* Experimental design: Phase III, open-label, non-randomised, multi-centric, single-country study with a single group. * Duration of the study: The intended duration of the study will be approximately 3 months per subject. * Treatment group and vaccination schedule: All subjects will receive three doses of the vaccine at 6, 10 and 14 weeks of age. * DTPa-IPV/Hib Group: Subjects who will receive DTPa-IPV/Hib vaccine (Infanrix-IPV/Hib). Other routine registered childhood vaccinations as part of National Immunisation Programme are permitted. Information regarding vaccine administered since birth until study completion will be collected and documented.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-12-01
- Primary completion
- 2018-08-01
- Completion
- 2018-08-01
- First posted
- 2017-04-25
- Last updated
- 2017-12-26
Source: ClinicalTrials.gov record NCT03128489. Inclusion in this directory is not an endorsement.