Jiangsu Provincial Centre for Disease Control and Prevention
Nanjing, Jiangsu, 210009, China
NCT Number: NCT03935204
This phase II clinical study was designed to evaluate the immunogenicity and safety of Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type)(E.Coli)(hereafter called HPV vaccine), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy adults aged 18-45 years old.
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Notify Me18 year–45 year
Female
Interventional
Phase 2
Nanjing, Jiangsu, 210009, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
HPV vaccine (270μg/1.0ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
Aluminium adjuvant (1.0ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
Other names: aluminium adjuvant
Time frame: month 7
To detect the anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific neutralizing antibody level on day 0 (before the 1st dose) and one month after dose 3
Time frame: During the 7-day (Day 0-6) period following each vaccination
Solicited local adverse reactions occurred within 7 days after each vaccination;
Time frame: During the 7-day (Day 0-6) period following each vaccination
Solicited systematic adverse reactions occurred within 7 days after each vaccination;
Time frame: Within 30 days (Day 0-29) after any vaccination
Unsolicited adverse reactions occurred within 30 days after each vaccination;
Time frame: throughout the study period, an average of 7 months
Serious adverse events occurred throughout the study;
Time frame: month 7
To detect the anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific IgG antibody level on day 0 (before the 1st dose) and one month after dose 3
Time frame: month 1,2 and 6
To detect the anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific neutralizing and IgG antibody level of a immunogenicity subgroup at month 1,2 and 6.
Xiamen University
Other
An Randomized, Double-Blinded, Placebo Controlled Phase II Clinical Trial to Estimate Immunogenicity of the Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type) (E.Coli) in Healthy Adults Aged 18 to 45 Years
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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