N/A
Completed N=3,013
A Post Marketing Surveillance (PMS) Study to Monitor the Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine in Female Chinese Subjects
Source: ClinicalTrials.gov NCT03438006 ↗Enrolled (actual)
3,013
Serious AEs
0.7%
Results posted
Sep 2021
Primary outcomePrimary: Number of Participants With Any (Following Each Dose and Across Doses), Grade 3 (Across Doses) and Vaccine Related (Across Doses) Medically Attended Adverse Events Following Immunisation (AEFIs) — 49; 55; 56; 147 Participants
Summary
The purpose of this prospective, multi-centre, PMS cohort study was to monitor the safety of Cervarix, which is the first HPV vaccine licensed for use in China, to help prevent cervical cancer caused by HPV types 16 and 18. The vaccine was approved by National Drug Administration of China (CNDA), in July 2016.
As per the CNDA commitment, this study collected data regarding the safety of the vaccine, related information on potential immune-mediated diseases (pIMDs); which are diseases that could affect the immune system, and the effect on pregnancy outcomes (POs) including birth defects in the newborn.
Cervarix was approved for use in females between 9-25 years of age, for the prevention of cervical cancer, cervical intraepithelial neoplasia grade 1 (CIN1), cervical intraepithelial neoplasia grade 2, grade 3 (CIN 2/3) and adenocarcinoma in situ caused by high-risk human papillomavirus (HR-HPV) types 16 and 18.
In May 2018, Cervarix was also approved for use in women of age up to 45 years.
The exposed set (ES) comprised 3013 subjects, who were vaccinated with Cervarix, on a voluntary basis, as per standard practice. The study collected information on any adverse event following immunisation, pIMDs, POs and congenital anomalies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any (Following Each Dose and Across Doses), Grade 3 (Across Doses) and Vaccine Related (Across Doses) Medically Attended Adverse Events Following Immunisation (AEFIs) |
49; 55; 56; 147; 1; 2 | — |
| SECONDARY Number of Participants With Any, Fatal and Vaccine Related Serious AEFIs (Across Doses) |
22; 0; 0 | — |
| SECONDARY Number of Participants With Any, Grade 3 and Vaccine Related Potential Immune Mediated Diseases (pIMDs) (Across Doses) |
1; 0; 0 | — |
| SECONDARY Number of Participants Reporting Pregnancies and Outcomes of Reported Pregnancies |
34; 1; 20; 0; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Any Chinese female subject aged between 9 and 45 years, at the time of first vaccination dose, who received voluntary vaccination.
- Subjects for whom the investigator believed that they or their parent(s)/LAR(s) could and complied with the requirements mentioned in the protocol (e.g., return for the subsequent dose of vaccination and follow-up visits) were included in the study.
- Written informed consent was obtained from the subject. For subjects who were below the legal age of consent, written informed consent were obtained from the parent(s)/LAR(s) of the subject and informed assent were obtained from the subject according to EC requirement as well as local law.
Exclusion Criteria
- Child in care
Data sourced from ClinicalTrials.gov (NCT03438006). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.