Trials / Unknown
UnknownNCT02710851
Immunogenicity Study of the Recombinant Human Papillomavirus Virus Type 6/11 Bivalent Vaccine
A PhaseⅡ Randomized, Double-Blinded, Placebo Controlled Study to Evaluate the Immunogenicity of the Recombinant (E.Coli) Human Papillomavirus Type 6/11 Bivalent Vaccine in Healthy Volunteers Aged 18-55 Years
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 640 (actual)
- Sponsor
- Jun Zhang · Academic / Other
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This phase Ⅱ clinical study was designed to evaluate the immunogenicity and safety of the novel recombinant HPV type 6/11 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged 18-55 years of age at enrollment. The study volunteers would be randomized to receive the 3 different formulations of the novel HPV vaccine or placebo vaccine (recombinant hepatitis E vaccine) administered intramuscularly according to a 0-1-6 month schedule. This is a double-blind study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | low dosage HPV Vaccine(1:1) | Participants would intramuscularly receive low dosage HPV bivalent vaccine with virus-like particles type 6 and 11 at 1:1 ratio. All participants would be invited to receive 3 doses vaccine at 0, 1, 6 month. |
| BIOLOGICAL | low dosage HPV Vaccine(1:2) | Participants would intramuscularly receive low dosage HPV bivalent vaccine with virus-like particles type 6 and 11 at 1:2 ratio. All participants would be invited to receive 3 doses vaccine at 0, 1, 6 month. |
| BIOLOGICAL | high dosage HPV Vaccine(1:1) | Participants would intramuscularly receive high dosage HPV bivalent vaccine with virus-like particles type 6 and 11 at 1:1 ratio. All participants would be invited to receive 3 doses vaccine at 0, 1, 6 month. |
| BIOLOGICAL | Hepatitis E vaccine,Hecolin® | Participants would intramuscularly receive Hepatitis E vaccine for 3 doses at 0, 1, 6 month. |
Timeline
- Start date
- 2016-03-24
- Primary completion
- 2023-12-30
- Completion
- 2023-12-30
- First posted
- 2016-03-17
- Last updated
- 2023-06-15
Source: ClinicalTrials.gov record NCT02710851. Inclusion in this directory is not an endorsement.