AzTrials
AzTrials

PneumoniaPCV1+1_FUNCT04275284

Persistence of Immunogenicity Following Reduced PCV Dosing Schedules in South African Children

An observational study of Pneumonia and Meningitis, run by University of Witwatersrand, South Africa at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will evaluate the persistence of immunogenicity following a reduced dosing schedule of 10- or 13-valent Pneumococcal Conjugate Vaccine (PCV10, PCV13). This is the follow-up of a randomized controlled trial in which children received a single priming dose of PCV10 or PCV13 (at 6 or 14 weeks of age) followed… Read more about this study

Who is it for?
Ages 3 to 5 years
Conditions the study is for
Pneumonia, Meningitis
What is being tested?
PCV10 and PCV13
Type of treatment
Injection or infusion
How many people
600 participants
Where
1 siteSouth Africa
Study dates
14 Feb 2020to 1 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 5 years
  • All sexes
  • Child

Study population: All participants who completed the PCV1+1 study and received all vaccines as specified per study protocol will be contacted to participate.

Who may be able to join

  • Children between and including the ages of 36 - 38 months of age at the time of first blood sampling;
  • Subjects who previously participated in the PCV1+1 study and received the full study vaccination regime as per protocol;
  • The parent or legal guardian of the child must be able and willing to provide written informed consent for all 3 visits and comply with all study requirements;
  • The parent or legal guardian of the child must indicate the intention to remain in the study area for the duration of the trial - or be willing to bring the child for all visits.

Who cannot join

  • Receipt of any additional pneumococcal vaccine since the end of participation in the PCV1+1 study;
  • Any known or suspected immunodeficiency condition which could affect immune response to vaccination, including living with HIV;
  • Receipt of any immunoglobulins and/or blood products less than 6 months prior to blood sampling;
  • Parent/legal guardian unable or unwilling to attend scheduled study visits.

Trial locations and contacts

1 site in 1 country.

South Africa1 site

  • Chris Hani Baragwanath Academic Hospital - DST/NRF VPD RMPRU

    Soweto, Gauteng, 2013

Other trials in South Africa

About this study

Official title: Evaluation of Persistence of Immunogenicity Following an Open-labelled, Randomized Controlled Trial Evaluating Non-inferiority of 1+1 Compared to 2+1 Dosing Schedules of 10-valent and 13-valent Pneumococcal Conjugate Vaccine in South Africa

This study will evaluate the persistence of immunogenicity following a reduced dosing schedule of 10- or 13-valent Pneumococcal Conjugate Vaccine (PCV10, PCV13). This is the follow-up of a randomized controlled trial in which children received a single priming dose of PCV10 or PCV13 (at 6 or 14 weeks of age) followed by booster dose at 9 months of age (1+1 schedule), compared to a 2+1 PCV schedule (6, 14 weeks of age and 9 months of age).

Read the detailed description

Between 2017 and 2019, we conducted an open-labelled, randomized controlled trial to evaluate for non-inferiority in the post-booster serotype-specific geometric mean concentrations (GMC's) in children randomized to receive either PCV10 or PCV13 as a 1+1 schedule (with the first dose occurring either at 6 or 14 weeks of age) compared to infants who received a two dose primary series (6 and 14 weeks of age). All six study groups received a booster dose at 40 weeks of age, and serotype-specific IgG and opsonophagocytic activity was measured one-month post booster. Subjects were planned to be followed-up until 18 months of age as part of the initial study. In the present study, we propose to extent the follow-up of the cohort to include annual visit at 3, 4 and 5 years of age, to evaluate the sustainability of the humoral immune response of the different PCV dosing schedules.

Being tested
PCV10, PCV13
Medical subject headings
Pneumonia, Meningitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PCV10Biological

    Also called Synflorix

    0.5 ml injection

  • PCV13Biological

    Also called Prevnar13

    0.5 ml injection

Study groups in NCT04275284
Study groupRoleWhat they receive
PCV10 1+1, 6 weeks & 9 monthsFollow-up of children who were previously randomized to PCV10 (Synflorix 0.5ml injection) administered at 6 weeks and 9 months of age.
Receives: Biological: PCV10
PCV13 1+1, 6 weeks & 9 monthsFollow-up of children who were previously randomized to PCV13 (Prevnar 13, 0.5ml injection) administered at 6 weeks and 9 months of age.
Receives: Biological: PCV13
PCV10 1+1, 14 weeks & 9 monthsFollow-up of children who were previously randomized to PCV10 (Synflorix 0.5ml injection) administered at 14 weeks and 9 months of age.
Receives: Biological: PCV10
PCV13 1+1, 14 weeks & 9 monthsFollow-up of children who were previously randomized to PCV13 (Prevnar 13, 0.5ml injection) administered at 14 weeks and 9 months of age.
Receives: Biological: PCV13
PCV10 2+1, 6&14 weeks & 9 monthsFollow-up of children who were previously randomized to PCV10 (Synflorix 0.5ml injection) administered at 6 weeks, 14 weeks and 9 months of age.
Receives: Biological: PCV10
PCV13 2+1, 6&14 weeks & 9 monthsFollow-up of children who were previously randomized to PCV13 (Prevnar 13, 0.5ml injection) administered at 6 weeks, 14 weeks and 9 months of age.
Receives: Biological: PCV13

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serotype specific geometric mean antibody concentrations (GMC)

    To evaluate persistence of vaccine-serotype specific GMCs at 3, 4 and 5 years of age between children receiving differing 1+1 dosing schedules compared to the 2+1 dosing schedule of the same vaccine formulation (i.e. PCV10 or PCV13).

    Measured: 3, 4 and 5 years of age

Secondary outcomes (3)

  1. Modified threshold of protection

    To evaluate persistence of vaccine-serotype specific serum IgG antibody concentration above the WHO-defined putative threshold for protection (≥0.35 µg/mL) and the modified serotype-specific correlate of protection against IPD as proposed by Andrews et al.(17) at 3, 4 and 5 years of between children with differing 1+1 dosing schedules compared to the 2+1 dosing schedule of the same vaccine formulation

    Measured: 3, 4 and 5 years of age

  2. Comparison between 6-week and 14-week primary dose

    To evaluate persistence of vaccine-serotype specific serum IgG antibody concentration above the WHO-defined putative threshold for protection (≥0.35 µg/mL), the modified serotype-specific correlate of protection against IPD as proposed by Andrews et al. (17) and GMC's at 3, 4 and 5 years in children receiving the 1+1 dosing schedule at either 6 weeks of age compared to those who received it at 14 weeks of age, stratified for the individual vaccine formulation (PCV10 and PCV13).

    Measured: 3, 4 and 5 years of age

  3. Colonization outcome

    To compare the prevalence of vaccine-serotype (stratified by PCV10 and PCV13 serotypes)

    Measured: 3, 4 and 5 years of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2020
  2. Study start14 Feb 2020
  3. Primary completion1 Dec 2022
  4. Study completion1 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04275284
Sponsor's protocol ID
PCV1+1 follow-up
Acronym
PCV1+1_FU
Status last verified
Aug 2024
First submitted
14 Feb 2020
Last updated
23 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Kapelus DJ, Olwagen CP, Izu A, Ranchod H, Mukendi CK, Mutsaerts EAML, Koen A, Jose L, Kwatra G, Faustini SE, Richter AG, Madhi SA. Immunogenicity up to age 5 years following a single-dose or two-dose infant primary series of 10-valent or 13-valent pneumococcal conjugate vaccine each followed by a booster dose in South Africa: extended follow-up of a single-centre, open-label, non-inferiority, randomised controlled trial. Lancet Child Adolesc Health. 2026 Sep 8:S2352-4642(26)00164-1. doi: 10.1016/S2352-4642(26)00164-1. Online ahead of print.

    PubMed 42710524

  • Olwagen CP, Izu A, Van der Merwe L, Jose L, Koen A, Madhi SA. Single priming and a booster dose of 10-valent and 13-valent pneumococcal conjugate vaccine (PCV) maintains suppression of vaccine serotype colonization in South African children at 3, 4, and 5 years of age: a single-centre, open-labelled, randomized trial. Expert Rev Vaccines. 2024 Jan-Dec;23(1):1011-1019. doi: 10.1080/14760584.2024.2417856. Epub 2024 Oct 22.

    PubMed 39417218

Questions about this trial

What is this clinical trial studying?

An observational study of Pneumonia and Meningitis, run by University of Witwatersrand, South Africa at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serotype specific geometric mean antibody concentrations (GMC) (time frame: 3, 4 and 5 years of age). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04275284, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in