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NCT05212623
A Clinical Trial of an Quadrivalent Inactivated Influenza Vaccine in Healthy Children Aged 6 to 35 Months
Phase 1 trial testing quadrivalent influenza split vaccine in Influenza in 120 participants. Completed in 16 June 2022.
17 January 2022
Quick facts
| Lead sponsor | Jiangsu Province Centers for Disease Control and Prevention |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 120 |
| Start date | 26 October 2021 |
| Primary completion | 17 January 2022 |
| Estimated completion | 16 June 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- quadrivalent influenza split vaccine — full drug profile →
- quadrivalent influenza split vaccine — full drug profile →
- Influenza virus split vaccine — full drug profile →
- Influenza virus split vaccine — full drug profile →
Conditions studied
- Influenza — all drugs for Influenza →
Sponsor
Jiangsu Province Centers for Disease Control and Prevention — full company profile →
Who can join
Adults 6 Months to 35 Months, any sex, with Influenza. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In this single-center, randomized, blinded, positive-controlled design, the investigators will assess the safety and immunogenicity of 2 doses of an inactivated quadrivalent influenza vaccine in children aged 6 to 35 months. About 120 healthy participants are planned to be enrolled, of who 60 participants were enrolled in the low-dose group and 60 participants were enrolled in the high-dose group. In the low-dose group, participants were randomly (2:1:1) assigned to receive a quadrivalent inactivated influenza vaccine (IIV4) at 0.25 mL including A/H1N1, A/H3N2, B/Victoria, and B/Yamagata, and a trivalent inactivated influenza vaccine (IIV3) at 0.25 mL including A/H1N1, A/H3N2 and B/Victoria, and IIV3 at 0.25 mL including A/H1N1, A/H3N2, and B/Yamagata. In the high-dose group, participants were randomly (2:1:1) assigned to receive IIV4 at 0.5 mL, and IIV3 at 0.25 mL including A/H1N1, A/H3N2, and B/Victoria, and IV3 at 0.25 mL including A/H1N1, A/H3N2, and B/Yamagata. Subjects receive 2 doses of influenza vaccine 4 weeks apart. The occurrence of adverse reactions within 30 minutes, the occurrence of adverse reactions within 28 days, and serious adverse events within 6 months after vaccination will be observed in all participants. For participants aged 24-35 months in each dose group, laboratory safety tests were measured before enrollment and on day 4 post each dose to assess any toxic effects. In addition, all subjects will be required to collect blood for HI antibody testing before the first dose of vaccination and 30 days after the second dose of vaccination.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05212623
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT07485855 — Influenza Vaccination Strategy for Patients With Hematologic Malignancy · Phase 3 · recruiting
Other Jiangsu Province Centers for Disease Control and Prevention trials
Trials by the same sponsor.
- NCT07530679 — Study on the Safety, Humoral Immune Response, and Memory B Cell Response Characteristics of Sequential 9-Valent HPV Vacc · NA · not yet recruiting
- NCT07232745 — Mucosal and Systemic Immune Responses Induced by an Intranasal Influenza Live Attenuated Vaccine · Phase 4 · active not recruiting
- NCT06609811 — The Interaction Between Mucosal Microbiota Colonization and the Immune Response to an Intranasal Influenza Live Attenuat · Phase 4 · completed
- NCT07035054 — Phase Ⅱ Clinical Trial of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine · Phase 2 · completed
- NCT07025876 — PhaseⅠClinical Trial of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine · EARLY_PHASE1 · 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 NCT05212623 (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 Jiangsu Province Centers for Disease Control and Prevention
- Last refreshed: 28 October 2022
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/NCT05212623.
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