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Sero-surveillance to assess rubella susceptibility including assessment of immunogenicity and safety of Rubella vaccine in females aged 18-24 years.

Sero-surveillance to assess Rubella susceptibility and assessment of immunogenicity and reactogenicity of Rubella vaccine (R-Vac®) in female students aged 18-24 years, of Symbiosis International University ( SIU).

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/091/000099
Enrollment
500
Registered
2011-02-07
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

Health Condition 1: Z23- Encounter for immunization

Interventions

Intervention1: Rubella vaccine: Single sub-cutaneous dose of 0.5 mg Control Intervention1: NIL: NIL

Sponsors

Serum Institute of India Research Foundation Pune Hadapsar Pune
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Female students aged 18-24 years at the time of enrollment. 2. Free of obvious health problems as established by medical history & clinical examination before entering into the study. 3. Written, Explained, Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period. 2. Administration of immunoglobulin or any blood products in last 3 months. 3. History of significant and persistent hematological, hepatic, renal, cardiac, respiratory, neurological disorders or seizure. 4. Axillary temperature ≥ 38.5 ° C. 5. Confirmed immunosuppression including HIV infection. 6. Major congenital or hereditary immunodeficiency. 7. Simultaneous participation in any other clinical study.

Design outcomes

Primary

MeasureTime frame
To estimate the proportion of females not having protective serum antibody titres against Rubella. Timepoint: Blood Sample to be drawn at the time of enrollment (pre-immunization).—

Secondary

MeasureTime frame
1. Rubella antibody titre 4-6 weeks after vaccination. 2. Clinical tolerability of the vaccine.Timepoint: 1. Blood Sample to be drawn 4-6 weeks after vaccination (post-immunization). 2. Safety asessment done until 4- 6 weeks following vaccination.—

Countries

India

Contacts

Public ContactDr Hitt Sharma

Serum Institute of India Ltd 212/2, Hadapsar

drhjs@seruminstitute.com02026602451

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026