To assess potential hazards, including immediate adverse events after bivalent and quadrivalent HPV vaccines immunizations in healthy Indian women aged 18-25 years.

Comparison of Post-licensure safety surveillance of Bivalent and Quadrivalent Human Papillomavirus vaccines in Healthy Women.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2013/11/004140

Enrollment

Registered

2013-11-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: GSK Biologicals HPV vaccine: Subjects will receive three doses of the study vaccine administered intramuscularly according to a Day 0, 1 and Month 6 vaccination schedule Intervention2:

Eligibility

Inclusion criteria

Inclusion criteria: 1. Able to fill the questionnaires used in this study. 2. Able to give a written informed consent. 3. Able to attend all scheduled visits.

Exclusion criteria

Exclusion criteria: 1. No hospitalization within 21 days prior to study entry. 2. Oral temperature of 38.3 C (101 F) or greater within 72 hours prior to each study vaccination. 3. Hypersensitivity to latex. 4. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. 5. They have surgery planned during the study period. 6. Pregnant or immune compromised women should be avoided. 7. Any other condition including abuse of alcohol, drug addiction of imposed confinement that may interfere with ability to comply with trial procedures.

Design outcomes

Primary

Measure	Time frame
1. To evaluate potential local injection site reactions and serious adverse events within 7 and 30 days after each dose of prophylactic bivalent and quadrivalent HPV vaccine.Timepoint: 1 year	—

Secondary

Measure	Time frame
1. To determine the occurrence, nature, duration, severity and relationship to vaccination of any local injection site reactions and serious adverse events. 2. To monitor whether the adverse events reported after vaccination with prophylactic bivalent and quadrivalent HPV vaccines the same as those expected and listed in the package insert.Timepoint: 12 months	—

Countries

India

Contacts

Public ContactVikrant Chandrakant Sangar

B. J. Govt. Medical College, Pune

ghongane.phdguide@gmail.com9922925590

Outcome results