A clinical study to assess protection against Rubella and also to assess the safety and immunogenicity of rubella vaccine in teenaged girls in Maharashtra

Serosurvey to assess Rubella IgG antibodies in teenaged girls in Maharashtra and to assess immunogenicity and reactogenicity of Rubella vaccine (R-Vac).

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000100

Enrollment

1200

Registered

2009-08-19

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: 0.5 ml subcutaneously single dose Control Intervention1: Nil: Nil

Eligibility

Inclusion criteria

Inclusion criteria: Healthy Schoolgirls aged 12 ? 15 years at the time of enrollment. Free of obvious health problems as established by medical history & clinical examination before entering into the study. Written, Explained, Signed informed consent of the parents / guardian. No evidence of any acute severe infection or moderate to severe Fever. Available for an study related procedures i.e. prevaccination blood sample, vaccination and post vaccination blood sample.

Exclusion criteria

Exclusion criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the study vaccine. History of receipt of Rubella containing vaccine/ History of confirmed rubella infection. Administration of immunoglobulin or any blood products in last 3 months. History of significant and persistent hematological, hepatic, renal, cardiac, respiratory, neurological disorders or seizure. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine including allergy to NEOMYCIN or POLYMYXIN-B. Confirmed immunosuppression including HIV infection. Simultaneous participation in any other clinical study.

Design outcomes

Primary

Measure	Time frame
Serosurveillance of IgG Rubella antibodies in teenaged girls.Timepoint: Antibody level assessment done at pre-vaccination.	—

Secondary

Measure	Time frame
Immunogenicity and reactogenicity assessment of Rubella vaccine.Timepoint: Immunogenicity assessment at pre-vaccination and six weeks post-vaccination. Reactogenicity assessment upto six weeks post-vaccination.	—

Countries

India

Contacts

Public ContactDr V S Padbidri

Serum Institute of India Ltd

drhjs@seruminstitute.com02026602451

Outcome results

None listed

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