ClinicalTrials.gg
Status unknownNCT05298800QIV;PPV23Updated Mar 28, 2022

Combined Immunization of COVID-19 Inactivated Vaccine With QIV and PPV23

A Phase 4 interventional study of Vaccine in Safety, Immunogenicity, Vaccine and COVID-19 Vaccines, sponsored by Centers for Disease Control and Prevention, China. Status unknown at 3 sites in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-28.

Sponsored by Centers for Disease Control and Prevention, China · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Oct 2021, registered Mar 2022).

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Phase
Phase 4
Study type
Interventional
Enrollment
3,000
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 173 studies in Influenza, Human with a site in China — 30 open to participants now, 37 under way, 10 of them phase 3. Influenza, Human · China.

Planned enrollment
14th of 157
3,000 · median 360
Started
2021
with 12 others
Phase 4
43 of 173
3 open now
Registered
107th of 173
by date

Among the 173 studies in Influenza, Human with a site in China, this one is the 14th largest by planned enrollment of the 157 interventional ones that give a count, is one of 13 that started in 2021, is one of 43 in phase 4, and was the 107th registered.

Influenza, Human

2,358 studies on the registry are indexed under Influenza, Human; 185 are open to participants now.

Browse Influenza, Human studies →

Open to participants now

30 of the 173 studies in Influenza, Human with a site in China are open now. Recruiting first, the newest first:

25 more — sign in →

All 30 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 120 Influenza, Human studies recruiting now, 64 (53%) set no upper age limit and 46 (38%) stop at 75 or younger; 33 take children under 18; 66 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

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02

Study summary

The main objective of this study was to evaluate the immunogenicity and safety of the booster dose of COVID-19 inactivated vaccine and co-immunization with quadrivalent influenza vaccine and 23-valent pneumonia polysaccharide vaccine in people aged 18 years and older. A randomized controlled, open trial design was adopted.

The study was conducted with informed consent of the subjects for immunogenicity and safety in the population aged 18 years and older. A total of 3000 healthy subjects were selected, (1)600 healthy subjects were selected for the immunogenicity and safety study of co-immunization, 300 in the adult group (18-59 years old) and 300 in the elderly group (60 years old and above); (2) 2400 healthy subjects were selected for the observational study of the safety of co-immunization, 1200 in the adult group (18-59 years old) and 1200 in the elderly group (60 years old and above ) 1200 people.

03

Conditions studied

  • Safety
  • Immunogenicity, Vaccine
  • COVID-19 Vaccines
  • Influenza Vaccines
  • Pneumococcal Vaccines

Browse trials for

Keywords

  • Safety;Immunogenecity;Combined Immunization
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy adults 18 years old and older
  • Over 6 months after primary immunization with COVID-19 vaccines
  • Can understand and sign the consent
  • Can provide effective personal identification

Exclusion criteria

Exclusion Criteria:

  • Has a history of COVID-19 infection
  • Less than 6 months after primary immunization with COVID-19 vaccines
  • Already vaccinated with influenza vaccines of that year
  • Vaccinated with pneumococcal vaccines within 5 years
  • Has a history of severe reaction to vaccines
  • Has uncontrolled seizure or other severe neural system illnesses
  • Has a fever, chronic disease, or acute disease during immunization
  • Gestation period, lactation period, or planning to get pregnant within 3 months
  • Administrated with other drugs under research within 30 days before vaccination
  • Received attenuated vaccines within 14 days before vaccination
  • Received subunit vaccines or inactivated vaccines within 7 days before vaccination
  • Other conditions based on researcher's judgement
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
3,000 participants (estimated)

Study arms

  • Experimental
    COVID-19 and QIV

    Biological: Vaccine

  • Experimental
    COVID-19 and PPV23

    Biological: Vaccine

  • Experimental
    COVID-19

    Biological: Vaccine

Interventions

  • BiologicalVaccine

    Different arms were administrated different vaccines

06

What researchers measure

Primary outcomes

  1. Seroconversion rate of neutralizing antibody

    Time frame: 28 days after the third dose of COVID-19 vaccine

07

Study locations

3 of 3 sites recruiting
  • Daxing District Center of Disease Control and Prevention
    Beijing, China
    Recruiting
    • Xin Song · Contact13810711075
  • Huairou District Center of Disease Control and Prevention
    Beijing, China
    Recruiting
    • Zhiquan Wei · Contact15201231087
  • Miyun District Center of Disease Control and Prevention
    Beijing, China
    Recruiting
    • Siyao Li · Contact1851596 9266
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2021 (actual). Primary completion is estimated for Dec 2022, 14 months after the start.

Of 101 non-industry phase 4 interventional studies under Influenza, Human, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 52. This study's planned 14 months is below that.

Counting every sponsor, half of 137 studies reached it within 14 months; a quarter within 3 and three quarters within 37.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 18, 2022
First posted
Mar 28, 2022
StartActual
Oct 8, 2021
Primary completionEst.
Dec 31, 2022
CompletionEst.
Dec 31, 2023
Last update
Mar 28, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05298800
Lead sponsor
Centers for Disease Control and Prevention, China
Responsible party
Wu Jiang (Director,Head of the Institute for Vaccines and Immunization, Centers for Disease Control and Prevention, China) — Principal investigator
First posted
Mar 28, 2022
Start date
Oct 8, 2021
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Mar 28, 2022

Study contacts

Jiang Wu, Bachelor
Contact
wj81732@hotmail.com
13381081732
Shuang Bai, Postgraduate
Contact
summer012388@hotmail.com
15210178395

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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