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Clinical Trials/CTRI/2010/091/000029
CTRI/2010/091/000029
Completed
Phase 2

A Randomized, Double Blind, Comparative, Phase II/III Study to Evaluate the Immunogenicity and Safety of Three Formulations [15 mcg (unadjuvanted), 7.5 mcg (adjuvanted) and 3.75 mcgg (adjuvanted)] of Monovalent H1N1 Influenza A (2009) Virus Vaccine, Manufactured by Panacea Biotec Ltd., in Healthy Pediatric Population 6 - 35 Months of Age. - H1N1 6-35 Months

Panacea Biotec Limited0 sites360 target enrollmentTBD
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Panacea Biotec Limited
Enrollment
360
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Subjects aged 6 \- 35 months whose parents/LAR gives a written informed consent prior to the study entry.
  • •2\.Subjects with good health as determined by:
  • •\* Medical history
  • •\* Physical examination
  • •\* Clinical judgment of the investigator

Exclusion Criteria

  • •1\.The parents or LAR are unwilling or unable to give written informed consent to participate in the study.
  • •2\.The subject is a case, cured case or has a history of close contact with influenza A (H1N1\) virus infected patients.
  • •3\.Subject having history of previous immunization with any pandemic or seasonal influenzae vaccine.
  • •4\.Subject with history of systemic hypersensitivity to any of the vaccine components, or history of a life\-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
  • •5\.Has received any live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to vaccination in this study, or plan receipt of such vaccines within 21 days following the second vaccination. The initiation of this protocol does not take precedence over routine immunizations.
  • •6\.Has a history of severe reactions following previous immunization with influenza virus vaccines
  • •7\.Subject allergic to egg or egg protein.
  • •8\.Subjects who are taking any antiviral drug either for treatment or prophylaxis against infection
  • •9\.Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) anytime since birth.
  • •10\.Have long term use of glucocorticoids including oral, parenteral or high\-dose inhaled steroids (\>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. (Nasal and topical steroids are allowed.)

Outcomes

Primary Outcomes

Not specified

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