Immunogenicity and Safety of Fractional Doses of IPV Intradermally vs Full Doses Intramuscularly

Immunogenicity and Safety of Fractional Doses of Sanofi Pasteur's Inactivated Poliomyelitis Vaccine Administered Intradermally vs Full Doses of Inactivated Poliomyelitis Vaccine Administered Intramuscularly in Healthy Philippines Infants

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00604058

Enrollment

236

Registered

2008-01-29

Start date

2008-01-31

Completion date

2008-12-31

Last updated

2014-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Poliomyelitis

Keywords

Poliomyelitis, intradermal

Brief summary

The present study intends to investigate the use of fractional doses of sanofi pasteur's IMOVAX Polio injected intradermally. The primary objective will be to demonstrate the non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full doses of IMOVAX Polio administered intramuscularly, in terms of seroprotection rates (polio types 1, 2 and 3) one month after the three-dose primary vaccination administered at 6-10-14 weeks of age.

Interventions

BIOLOGICALInactivated Poliomyelitis vaccine (IMOVAX)

Fractional dose (1/5th) 0.1 mL, intradermally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

42 Days to 50 Days

Healthy volunteers

Yes

Inclusion criteria

* Inclusion Criteria to be checked at the screening visit (SC): * Aged 0 to 7 days on the day of screening * Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg * Informed consent form signed by the parent(s) or other legally acceptable representative * Subjects and parent/guardian able to attend all scheduled visits and comply with all trial procedures * Inclusion Criteria to be checked at the randomization visit (V01): * Aged 42 to 50 days on the day of inclusion * Subjects and parent/guardian able to attend all scheduled visits and comply with all trial procedures

Exclusion criteria

Design outcomes

Primary

Measure	Time frame
The non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full doses of IMOVAX Polio administered intramuscularly, in terms of seroprotection rates (polio types 1 2 and 3) one month after the three-dose primary vaccination	1 Month Post-vaccination

Secondary

Measure	Time frame
Immunogenicity: To assess and describe in each group the immunogenicity of the study vaccines one month after the three-dose primary vaccination Safety: To describe in each group the safety after each dose of the study vaccines	1 Month post-vaccination

Countries

Philippines

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026