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NCT02560272
A Phase III, Double Blind, Parallel-controlled, Randomised Study to Evaluate the Safety and Immunogenicity of Haemophilus Influenzae Type b Conjugate Vaccine in Healthy Children 2 Months to 5 Years of Age
Phase 3 trial testing Minhai-HIB in Haemophilus Influenzae Type b Infections in 1,560 participants. Status unknown.
1 December 2015
Quick facts
| Lead sponsor | Beijing Minhai Biotechnology Co., Ltd |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 1,560 |
| Start date | 1 September 2014 |
| Primary completion | 1 December 2015 |
| Estimated completion | 1 June 2016 |
| Sites | 1 location across China |
Drugs / interventions tested
- Minhai-HIB — full drug profile →
- Act-HIB® — full drug profile →
Conditions studied
- Haemophilus Influenzae Type b Infections — all drugs for Haemophilus Influenzae Type b Infections →
Sponsor
Beijing Minhai Biotechnology Co., Ltd — full company profile →
Who can join
Adults 2 Months to 5, any sex, with Haemophilus Influenzae Type b Infections. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL
Time frame: 28 days after last dose of primary vaccination
Sponsor's own description
The study will evaluate the safety and immunogenicity of a haemophilus influenzae type b conjugate vaccine (Hib) in Healthy Children 2 Months to 5 Years of Age who have not been previously immunized with a Hib vaccine. Children 2 to 5 months of age will receive 3 doses of Hib vaccine, Children 6 to 11 months of age will receive 2 doses of Hib vaccine, Children 1 to 5 years of age will receive 1 dose of Hib vaccine, with each dose given approximately 1 month apart.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02560272
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Beijing Minhai Biotechnology Co., Ltd trials
Trials by the same sponsor.
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- NCT06752174 — A Study to Evaluate Safety and Immunogenicity of Sequential Vaccination of Sabin Inactivated Poliomyelitis Vaccine (Vero · Phase 3 · completed
- NCT04756323 — A Study to Evaluate Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged · Phase 2 · unknown
- NCT04758273 — A Safety and Immunogenicity Study of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 18 Years and · Phase 1 · unknown
- NCT06210737 — A Study to Evaluate Persistence of Immunity of PCV13 in Healthy Population Aged 2 Months，7 Months-5 Years · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02560272 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beijing Minhai Biotechnology Co., Ltd
- Last refreshed: 24 September 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02560272.
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