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PneumoniaPhase 3PCV1+1NCT02943902

Reduced PCV Dosing Schedules in South African Infants

A Phase 3 study testing Pneumococcal conjugate vaccine (PCV10 ) 1+1, 6 weeks, Pneumococcal conjugate vaccine (PCV10 ) 1+1, 14 weeks and Pneumococcal conjugate vaccine (PCV10 ) 2+1 in people with Pneumonia and Meningitis, run by University of Witwatersrand, South Africa at 2 sites in South Africa.

Completed

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

Official record
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Trial summary

This study will evaluate the immunogenicity of a reduced dosing schedule of Pneumococcal Conjugate vaccine (PCV) PCV10 and PCV13, in which children will receive a primary dose at either 6 or 14 weeks of age, followed by a booster dose at 9 months of age (1+1 schedule), and compare this immune response to those who… Read more about this study

Who is it for?
Ages 5 weeks to 18 monthsHealthy volunteers can take part
Conditions the study is for
Pneumonia, Meningitis
What is being tested?
Pneumococcal conjugate vaccine (PCV10 ) 1+1, 6 weeks, Pneumococcal conjugate vaccine (PCV10 ) 1+1, 14 weeks and Pneumococcal conjugate vaccine (PCV10 ) 2+1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
2 sitesSouth Africa
Study dates
9 Jan 2017to 26 Feb 2019
Phase
Phase 3
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 5 weeks to 18 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Signed informed consent by the parent/guardian of the child;
  • Born to an HIV-uninfected women, based on testing undertaken as part of standard of care during the last trimester of pregnancy;
  • Had not received any vaccine other than BCG and OPV (routinely given at birth) prior to enrolment;
  • Birth weight >2499g AND weight of child >3.5 kg at time of proposed randomization;
  • Aged 42-56 days of age at time of enrolment;
  • Available for the duration of the study;
  • Child is healthy based on medical history and physical examination of the study-staff.

Who cannot join

  • Any clinically significant major congenital abnormalities;
  • Previous hospitalization for a respiratory illness following discharge from hospital after birth;
  • Receipt of any other investigational drug/vaccine. Co-enrollment into non-investigational studies, including epidemiology studies, is allowed;
  • Any previous PCV vaccination;
  • Known allergy to any of the vaccine components;
  • Febrile illness (axillary temperature ≥37.8°C) at time of enrolment. These participants are eligible if the temperature resolves for at least 48 hours and they remain within the study defined window periods;
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  • Planned relocation to outside of the study area during up until age of 2 years;
  • Receipt of blood transfusion or any other blood products (including immunoglobulins) since birth. Receipt of such products during the course of the study, will require withdrawal of the child from the study;
  • History of confirmed pneumococcal disease since birth;
  • Any known or suspected immunodeficiency condition which could affect immune response to vaccination.

Trial locations and contacts

2 sites in 1 country.

South Africa2 sites

  • Chris Hani Baragwanath Academic Hospital

    Johannesburg, Gauteng

  • Nrf/Dst Vpd Rmpru

    Soweto, GP, 2055

Other trials in South Africa

About this study

Official title: An Open-labeled, Randomized Controlled Trial Evaluating for Non-inferiority of 1+1 Compared to 2+1 Dosing Schedules of 10-valent and 13-valent Pneumococcal Conjugate Vaccine (PCV) in South African Children

This study will evaluate the immunogenicity of a reduced dosing schedule of Pneumococcal Conjugate vaccine (PCV) PCV10 and PCV13, in which children will receive a primary dose at either 6 or 14 weeks of age, followed by a booster dose at 9 months of age (1+1 schedule), and compare this immune response to those who receive a two dose primary series (at 6 and 14 weeks of age) and booster dose at 9-months (2+1 schedule).

Read the detailed description

Pneumonia is the leading global cause of childhood death outside of the neonatal period, and contributes to 19% of the 10 million childhood deaths occurring annually, the majority of which occurs in industrialising countries. Despite the successes in improving primary healthcare in South Africa since 1994, pneumonia nevertheless remains a leading cause of childhood death in South Africa, aggravated by the HIV/AIDS epidemic. Streptococcus pneumoniae is recognised as the leading bacterial cause of pneumonia in children as well as having been identified as a common cause of super-imposed bacterial infection in individuals with respiratory virus-associated pneumonia.

In South Africa, the cost of procurement of PCV ($20 per dose) totals almost 50% of the total cost of all vaccines purchased for the national immunisation program. Similarly, PCV is the most expensive vaccine purchased by the Global Alliance for Vaccines and Immunisation (GAVI), which heavily funds vaccine procurement for low income countries. The sustainability of continued procurement of this vaccine at the current pricing in low-middle income countries remains uncertain.

This will be a randomized, open-label study (laboratory personnel will however be blinded) in which subjects are randomized to one of two (primary dose at either 6 or 14 weeks of age) 1+1 dosing schedules of PCV10 or PCV13, or to a 2+1 schedule of these vaccines. A total of 600 subjects will be randomized in a 1:1:1:1:1:1 ratio to one of the six groups. The study will be undertaken at an experienced research site in Johannesburg, South Africa, where the 600 children born to HIV-uninfected women are expected to be enrolled over a 12- month period.

Being tested
Pneumococcal conjugate vaccine (PCV10 ) 1+1, 6 weeks, Pneumococcal conjugate vaccine (PCV10 ) 1+1, 14 weeks, Pneumococcal conjugate vaccine (PCV10 ) 2+1, Pneumococcal conjugate vaccine (PCV13 ) 1+1, 6 weeks, Pneumococcal conjugate vaccine (PCV13 ) 1+1, 14 weeks
Keywords
immunogenicity
Medical subject headings
Pneumonia, Meningitis

What participants receive

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

  • Pneumococcal conjugate vaccine (PCV10 ) 1+1, 6 weeksBiological

    Also called Synflorix (PCV10)

    PCV10 1+1, 6 weeks \& 9 months

  • Pneumococcal conjugate vaccine (PCV10 ) 1+1, 14 weeksBiological

    Also called Synflorix (PCV10)

    PCV10 1+1, 14 weeks \& 9 months

  • Pneumococcal conjugate vaccine (PCV10 ) 2+1Biological

    Also called Synflorix (PCV10)

    PCV10 2+1, 6\&14 weeks \& 9 months

  • Pneumococcal conjugate vaccine (PCV13 ) 1+1, 6 weeksBiological

    Also called Prevenar 13

    PCV13 1+1, 6 weeks \& 9 months

  • Pneumococcal conjugate vaccine (PCV13 ) 1+1, 14 weeksBiological

    Also called Prevenar 13

    PCV13 1+1, 14 weeks \& 9 months

  • Pneumococcal conjugate vaccine (PCV13 ) 2+1Biological

    Also called Prevenar 13

    PCV13 2+1, 6\&14 weeks \& 9 months

Study groups in NCT02943902
Study groupRoleWhat they receive
Group 1a (1+1, 6 weeks)ExperimentalPCV10 (Synflorix 0.5ml injection) will be administered at 6 weeks and 9 months of age
Receives: Biological: Pneumococcal conjugate vaccine (PCV10 ) 1+1, 6 weeks
Group 1b (1+1, 6 weeks)ExperimentalPCV13 (Prevenar 13, 0.5ml injection) will be administered at 6 weeks and 9 months of age
Receives: Biological: Pneumococcal conjugate vaccine (PCV13 ) 1+1, 6 weeks
Group 2a (1+1, 14 weeks)ExperimentalPCV10 (Synflorix 0.5ml injection) will be administered at 14 weeks and 9 months of age
Receives: Biological: Pneumococcal conjugate vaccine (PCV10 ) 1+1, 14 weeks
Group 2b (1+1, 14 weeks)ExperimentalPCV13 (Prevenar 13, 0.5ml injection) will be administered at 14 weeks and 9 months of age
Receives: Biological: Pneumococcal conjugate vaccine (PCV13 ) 1+1, 14 weeks
Group 3a (2+1)Active comparatorPCV10 (Synflorix 0.5ml injection) will be administered at 6 weeks, 14 weeks and 9 months of age, as per EPI schedule in South Africa
Receives: Biological: Pneumococcal conjugate vaccine (PCV10 ) 2+1
Group 3b (2+1)Active comparatorPCV13 (Prevenar 13, 0.5ml injection) will be administered at 6 weeks, 14 weeks and 9 months of age, as per EPI schedule in South Africa
Receives: Biological: Pneumococcal conjugate vaccine (PCV13 ) 2+1

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) one month following the booster dose

    The serotype-specific GMC measured 1 month after the 9-month booster dose for each 1+1 vaccine group and comparing it to the 2+1 group of the same vaccine

    Measured: 1 month post booster vaccine

Secondary outcomes (1)

  1. Immunogenicity: percentage of children with vaccine-serotype specific serum IgG antibody concentration above the WHO-defined putative threshold for protection (≥0.35 µg/mL) at 9 months of age, prior to the booster dose of differing 1+1 dosing schedules

    1. To evaluate the percentage of children with vaccine-serotype specific serum IgG antibody concentration above the WHO-defined putative threshold for protection (≥0.35 µg/mL) at 9 months of age, prior to the booster dose of differing 1+1 dosing schedules (i.e. primary dose given at either 6 or 14 weeks of age) compared to that of children who received a 2 dose primary series (i.e. 2+1 dosing schedule group)..

    Measured: 9 months 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 posted25 Oct 2016 (estimated)
  2. Study start9 Jan 2017
  3. Primary completion26 Feb 2019
  4. Study completion26 Feb 2019

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02943902
Sponsor's protocol ID
PCV1+1
Acronym
PCV1+1
Status last verified
Dec 2019
First submitted
21 Oct 2016
Last updated
9 Dec 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: The data will be made publically available, within one year of completion of the study to any investigators or BMGF nominated partners, who wish to use the data to address any specific questions not directly addressed under the study objectives and which the data would lend itself to

Publications

  • Izu A, Mutsaerts EA, Olwagen C, Jose L, Koen A, Nana AJ, Cutland CL, Madhi SA. Serotype-specific serum immunoglobulin G at 18 months of age following one or two doses of a primary series of 10-valent or 13-valent pneumococcal conjugate vaccine and a booster dose at nine months of age: a randomized controlled study. Expert Rev Vaccines. 2025 Dec;24(1):121-127. doi: 10.1080/14760584.2025.2458179. Epub 2025 Jan 27.

    PubMed 39865559

  • Mutsaerts EAML, van Cranenbroek B, Madhi SA, Simonetti E, Arns AJ, Jose L, Koen A, van Herwaarden AE, de Jonge MI, Verhagen LM. Impact of nutritional status on vaccine-induced immunity in children living in South Africa: Investigating the B-cell repertoire and metabolic hormones. Vaccine. 2024 May 22;42(14):3337-3345. doi: 10.1016/j.vaccine.2024.04.034. Epub 2024 Apr 17.

    PubMed 38637212

  • Olwagen CP, Izu A, Mutsaerts EAML, Jose L, Koen A, Downs SL, Van Der Merwe L, Laubscher M, Nana AJ, Moultrie A, Cutland CL, Dorfman JR, Madhi SA. Single priming and booster dose of ten-valent and 13-valent pneumococcal conjugate vaccines and Streptococcus pneumoniae colonisation in children in South Africa: a single-centre, open-label, randomised trial. Lancet Child Adolesc Health. 2023 May;7(5):326-335. doi: 10.1016/S2352-4642(23)00025-1. Epub 2023 Mar 16.

    PubMed 36934731

  • Madhi SA, Mutsaerts EA, Izu A, Boyce W, Bhikha S, Ikulinda BT, Jose L, Koen A, Nana AJ, Moultrie A, Roalfe L, Hunt A, Goldblatt D, Cutland CL, Dorfman JR. Immunogenicity of a single-dose compared with a two-dose primary series followed by a booster dose of ten-valent or 13-valent pneumococcal conjugate vaccine in South African children: an open-label, randomised, non-inferiority trial. Lancet Infect Dis. 2020 Dec;20(12):1426-1436. doi: 10.1016/S1473-3099(20)30289-9. Epub 2020 Aug 25.

    PubMed 32857992

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pneumococcal conjugate vaccine (PCV10 ) 1+1, 6 weeks, Pneumococcal conjugate vaccine (PCV10 ) 1+1, 14 weeks and Pneumococcal conjugate vaccine (PCV10 ) 2+1 in people with Pneumonia and Meningitis, run by University of Witwatersrand, South Africa at 2 sites 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 7 inclusion and 10 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 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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) one month following the booster dose (time frame: 1 month post booster vaccine). 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 NCT02943902, which also lists 4 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 9 Dec 2019.

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