Pneumonia, PneumococcalMSIP PCVNCT04923035
Paediatric Pneumococcal Pneumonia in Malaysia Prior to and During Pneumococcal Conjugate Vaccine (PCV) Implementation
An observational study of Pneumonia, Pneumococcal and Pneumonia Childhood, run by IMU University, Malaysia at 3 sites in Malaysia.
Trial summary
The purpose of this research is to provide baseline surveillance of pneumonia in young children in Malaysia before and during the implementation of the pneumococcal conjugate vaccine (PCV). Read more about this study
- Who is it for?
- Ages 1 month to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumonia, Pneumococcal, Pneumonia Childhood
- How many people
- 1,010 participants
- Where
- 3 sitesMalaysia
- Study dates
- 13 Oct 2021to Dec 2024
- 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 1 month to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: This is a prospective case-control study in which all children aged 5 years and below with clinically diagnosed community-acquired pneumonia and healthy controls will be recruited at three study sites. As per assumptions of 95% confidence interval (CI), 80% power and detectable odds ratio (OR) of 1.5, The investigators estimate 164 cases and 164 healthy controls per each sentinel hospital site. Thus, the investigators aim to recruit a total of 500 confirmed pneumonia cases and 500 healthy controls for this study.
Who may be able to join
- Any child aged 5 years and below who meets the case and control definition and whose parent/legal authorized representative (LAR) is willing to give consent on his/her behalf.
Who cannot join
- who does not meet the case and control definition
- whose parent/guardian does not give consent on his/her behalf
- who has nasal surgery
Trial locations and contacts
3 sites in 1 country.
Malaysia3 sites
Hospital Universiti Sains Malaysia
Kota Bharu, Kelantan, 16150
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 57000
Sultan Ahmad Shah Medical Centre @International Islamic University Malaysia
Kuantan, Pahang, 57000
About this study
Official title: Evaluating the Burden of Paediatric Pneumococcal Pneumonia in Malaysia Prior to and During Pneumococcal Conjugate Vaccine (PCV) Implementation
The purpose of this research is to provide baseline surveillance of pneumonia in young children in Malaysia before and during the implementation of the pneumococcal conjugate vaccine (PCV). Pneumonia is a respiratory infection that can cause mild to life-threatening disease among all age groups but is the leading infectious cause of death among children globally. The most common cause of pneumonia is infection with a bacteria called Streptococcus pneumoniae, also known as pneumococcus. Hence, immunisation with a pneumococcal vaccine is an effective way to prevent pneumonia. In Malaysia, pneumococcal vaccination under the National Immunisation Programme (NIP) for children has since commenced in December 2020, comprising of 3 doses at four, six and 15 months. The routine use of PCV in children will contribute to reducing the burden of pneumococcal infections in the country, especially severe infections. The ongoing COVID-19 pandemic may also have implications on the pneumococcal serotype and clinical presentation of infections in the community.
Read the detailed description
This study will be a multi-centre prospective case-control study and the recruitment of clinically diagnosed pneumonia patients and healthy controls aged 5 years and below will be conducted at the three university hospitals; University Malaya Medical Centre (UMMC), Sultan Ahmad Shah Medical Centre@International Islamic University Malaysia (SASMEC@IIUM) and Hospital University Sains Malaysia (HUSM). Subject recruitment and sample collection will be carried out for 24 months. Informed consent and general questionnaire will be administrated by the on-site researchers. Clinical samples will be taken according to approved protocol and local policy to include nasopharyngeal (NP) swab and urine sample. NP swab in a transport medium will be store at -80°C before shipment to the International Medical University (IMU) Advanced Microbiology Collaborative Research Laboratory (AMCRL) in Kuala Lumpur for polymerase chain reaction (PCR) analysis. The data obtained may provide crucial data to support policy decisions on pneumococcal vaccination.
. Specific Objectives
- To determine the prevalence of Streptococcus pneumoniae (SPN) nasopharyngeal (NP) carriage among children 5 years of age and below with pneumonia and invasive pneumonia disease (IPD) using polymerase chain reaction (PCR) analysis.
- To determine SPN serotypes in young children during the coronavirus disease 2019 (COVID-19) pandemic by whole-genome sequencing analysis.
- To identify potential changes in clinical presentation and severity of pneumococcal infection in young children during the COVID-19 pandemic.
- To evaluate the correlations between SPN serotypes detected in NP carriage and urine sample from the same individual/child.
- To estimate sensitivity and specificity for SPN serotypes detection in urine among children with pneumonia and IPD.
- Conditions
- Pneumonia, Pneumococcal, Pneumonia Childhood
- Keywords
- surveillance, polymerase chain reaction, whole-genome sequencing, pneumococcal urine antigen detection, correlation analysis
- Medical subject headings
- Pneumonia, Pneumococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case | Children aged 5 years and below with clinically diagnosed pneumonia and attending the outpatient's department or admitted as a hospital inpatient at three sentinel sites. Pneumonia. Suspected pneumonia cases will be identified by a family physician or paediatrician based on medical history and clinical symptoms. Pneumonia is defined as (WHO Fact Sheet 2019) patient with history of: 1. cough and/or 2. difficulty/rapid breathing and/or 3. intercostal recession, 4. with or without fever. and supported by chest x-ray findings. | |
| Control | Healthy children aged 5 years and below without any intercurrent respiratory illness and who is in good health as determined by a brief medical history and/or clinical judgement of the investigator whose parent/LAR is willing and able to give informed consent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasopharyngeal (NP) pneumococcal carriages prevalence rate among young children
The absence/presence of nasopharyngeal pneumococcal carriages will be tested using standard bacteriological methods and Streptococcus Pneumoniae (SPN) isolates will be inoculated for DNA extraction and further tested by polymerase chain reaction (PCR) for pneumococcal carriage detection.
Measured: 24 months
Secondary outcomes (1)
Streptococcus pneumoniae (SPN) detection in urine samples among young children
To evaluate the correlations between SPN isolates detected in NP carriage and urine sample from the same individual/child.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start13 Oct 2021
- Primary completion29 Aug 2023
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, PneumococcalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,010 participants (actual)
Sponsor and investigators
- Lead sponsor
- IMU University, Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malaya, Universiti Sains Malaysia, International Islamic University Malaysia, University of Southampton, Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Lokman Hakim Sulaiman, MD, IMU University, Malaysia
- Investigators
- Lokman Hakim H Sulaiman, PhD, Principal investigator, IMU University, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923035
- Sponsor's protocol ID
- MISP #60200
- Acronym
- MSIP PCV
- Status last verified
- Jan 2024
- First submitted
- 1 Jun 2021
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
La Vincente SF, von Mollendorf C, Ulziibayar M, Satzke C, Dashtseren L, Fox KK, Dunne EM, Nguyen CD, de Campo J, de Campo M, Thomson H, Surenkhand G, Demberelsuren S, Bujinlkham S, Do LAH, Narangerel D, Cherian T, Mungun T, Mulholland EK. Evaluation of a phased pneumococcal conjugate vaccine introduction in Mongolia using enhanced pneumonia surveillance and community carriage surveys: a study protocol for a prospective observational study and lessons learned. BMC Public Health. 2019 Mar 21;19(1):333. doi: 10.1186/s12889-019-6639-y.
PubMed 30898094Adetifa IMO, Adamu AL, Karani A, Waithaka M, Odeyemi KA, Okoromah CAN, Bello MM, Abubakar IS, Inem V, Scott JAG. Nasopharyngeal Pneumococcal Carriage in Nigeria: a two-site, population-based survey. Sci Rep. 2018 Feb 22;8(1):3509. doi: 10.1038/s41598-018-21837-5.
PubMed 29472635Tan ACH, Ramzi NH, Johari NA, Lai PK, Wong S, Chang XQ, Lin EEJ, Lum XR, Roslan AHM, Nathan AM, Teh CSJ, Ilias MI, Deris ZZ, Bakar AA, Helmi MAM, Kamarudin N, Sulaiman LH. Co-carriage of respiratory tract bacterial pathogens among under-5 children with pneumococcal carriage in Peninsular Malaysia. BMC Infect Dis. 2026 Feb 12;26(1):578. doi: 10.1186/s12879-026-12800-1.
PubMed 41680649Ramzi NH, Hoong ATC, Johari NA, Nathan AM, Teh CSJ, Sulaiman NA, Ilias MI, Deris ZZ, Hazlan SNH, Nasir NSM, Bakar AA, Helmi MAM, Juhari WKW, Kamarudin N, Chong CW, Cleary DW, Clarke SC, Sulaiman LH. Multicentre case-control study of pneumococcal infections among children with pneumonia in Peninsular Malaysia (MY-Pneumo): a study protocol. BMC Public Health. 2024 Aug 20;24(1):2255. doi: 10.1186/s12889-024-19789-9.
PubMed 39164673
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Burden of Paediatric Pneumococcal Pneumonia in Malaysia Prior to and During Pneumococcal Conjugate Vaccine (PCV) Implementation
- ClinicalTrials.gov ID
- NCT04923035
- Acronym / sponsor ID
- MSIP PCV / MISP #60200
- Conditions
- Pneumonia, Pneumococcal, Pneumonia Childhood
- Keywords
- surveillance, polymerase chain reaction, whole-genome sequencing, pneumococcal urine antigen detection, correlation analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,010 participants (actual)
- Lead sponsor
- IMU University, MalaysiaUniversity, hospital or other
- Collaborators
- University of Malaya, Universiti Sains Malaysia, International Islamic University Malaysia, University of Southampton, Merck Sharp & Dohme LLC
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- 29 Aug 2023 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to provide baseline surveillance of pneumonia in young children in Malaysia before and during the implementation of the pneumococcal conjugate vaccine (PCV). Pneumonia is a respiratory infection that can cause mild to life-threatening disease among all age groups but is the leading infectious cause of death among children globally. The most common cause of pneumonia is infection with a bacteria called Streptococcus pneumoniae, also known as pneumococcus. Hence, immunisation with a pneumococcal vaccine is an effective way to prevent pneumonia. In Malaysia, pneumococcal vaccination under the National Immunisation Programme (NIP) for children has since commenced in December 2020, comprising of 3 doses at four, six and 15 months. The routine use of PCV in children will contribute to reducing the burden of pneumococcal infections in the country, especially severe infections. The ongoing COVID-19 pandemic may also have implications on the pneumococcal serotype and clinical presentation of infections in the community.
Detailed description
This study will be a multi-centre prospective case-control study and the recruitment of clinically diagnosed pneumonia patients and healthy controls aged 5 years and below will be conducted at the three university hospitals; University Malaya Medical Centre (UMMC), Sultan Ahmad Shah Medical Centre@International Islamic University Malaysia (SASMEC@IIUM) and Hospital University Sains Malaysia (HUSM). Subject recruitment and sample collection will be carried out for 24 months. Informed consent and general questionnaire will be administrated by the on-site researchers. Clinical samples will be taken according to approved protocol and local policy to include nasopharyngeal (NP) swab and urine sample. NP swab in a transport medium will be store at -80°C before shipment to the International Medical University (IMU) Advanced Microbiology Collaborative Research Laboratory (AMCRL) in Kuala Lumpur for polymerase chain reaction (PCR) analysis. The data obtained may provide crucial data to support policy decisions on pneumococcal vaccination.
. Specific Objectives
- To determine the prevalence of Streptococcus pneumoniae (SPN) nasopharyngeal (NP) carriage among children 5 years of age and below with pneumonia and invasive pneumonia disease (IPD) using polymerase chain reaction (PCR) analysis.
- To determine SPN serotypes in young children during the coronavirus disease 2019 (COVID-19) pandemic by whole-genome sequencing analysis.
- To identify potential changes in clinical presentation and severity of pneumococcal infection in young children during the COVID-19 pandemic.
- To evaluate the correlations between SPN serotypes detected in NP carriage and urine sample from the same individual/child.
- To estimate sensitivity and specificity for SPN serotypes detection in urine among children with pneumonia and IPD.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | –Children aged 5 years and below with clinically diagnosed pneumonia and attending the outpatient's department or admitted as a hospital inpatient at three sentinel sites. Pneumonia. Suspected pneumonia cases will be identified by a family physician or paediatrician based on medical history and clinical symptoms. Pneumonia is defined as (WHO Fact Sheet 2019) patient with history of: 1. cough and/or 2. difficulty/rapid breathing and/or 3. intercostal recession, 4. with or without fever. and supported by chest x-ray findings. |
| Control | – | –Healthy children aged 5 years and below without any intercurrent respiratory illness and who is in good health as determined by a brief medical history and/or clinical judgement of the investigator whose parent/LAR is willing and able to give informed consent. |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This is a prospective case-control study in which all children aged 5 years and below with clinically diagnosed community-acquired pneumonia and healthy controls will be recruited at three study sites. As per assumptions of 95% confidence interval (CI), 80% power and detectable odds ratio (OR) of 1.5, The investigators estimate 164 cases and 164 healthy controls per each sentinel hospital site. Thus, the investigators aim to recruit a total of 500 confirmed pneumonia cases and 500 healthy controls for this study.
Key inclusion criteria (1 listed)
- Any child aged 5 years and below who meets the case and control definition and whose parent/legal authorized representative (LAR) is willing to give consent on his/her behalf.
Key exclusion criteria (3 listed)
- who does not meet the case and control definition
- whose parent/guardian does not give consent on his/her behalf
- who has nasal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nasopharyngeal (NP) pneumococcal carriages prevalence rate among young children
Time frame: 24 months
The absence/presence of nasopharyngeal pneumococcal carriages will be tested using standard bacteriological methods and Streptococcus Pneumoniae (SPN) isolates will be inoculated for DNA extraction and further tested by polymerase chain reaction (PCR) for pneumococcal carriage detection.
1 secondary outcome
Streptococcus pneumoniae (SPN) detection in urine samples among young children
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Results publication: PubMed 30898094La Vincente SF, von Mollendorf C, Ulziibayar M, Satzke C, Dashtseren L, Fox KK, Dunne EM, Nguyen CD, de Campo J, de Campo M, Thomson H, Surenkhand G, Demberelsuren S, Bujinlkham S, Do LAH, Narangerel D, Cherian T, Mungun T, Mulholland EK. Evaluation of a phased pneumococcal conjugate vaccine introduction in Mongolia using enhanced pneumonia surveillance and community carriage surveys: a study protocol for a prospective observational study and lessons learned. BMC Public Health. 2019 Mar 21;19(1):333. doi: 10.1186/s12889-019-6639-y.
- Results publication: PubMed 29472635Adetifa IMO, Adamu AL, Karani A, Waithaka M, Odeyemi KA, Okoromah CAN, Bello MM, Abubakar IS, Inem V, Scott JAG. Nasopharyngeal Pneumococcal Carriage in Nigeria: a two-site, population-based survey. Sci Rep. 2018 Feb 22;8(1):3509. doi: 10.1038/s41598-018-21837-5.
- Derived from this study: PubMed 41680649Tan ACH, Ramzi NH, Johari NA, Lai PK, Wong S, Chang XQ, Lin EEJ, Lum XR, Roslan AHM, Nathan AM, Teh CSJ, Ilias MI, Deris ZZ, Bakar AA, Helmi MAM, Kamarudin N, Sulaiman LH. Co-carriage of respiratory tract bacterial pathogens among under-5 children with pneumococcal carriage in Peninsular Malaysia. BMC Infect Dis. 2026 Feb 12;26(1):578. doi: 10.1186/s12879-026-12800-1.
- Derived from this study: PubMed 39164673Ramzi NH, Hoong ATC, Johari NA, Nathan AM, Teh CSJ, Sulaiman NA, Ilias MI, Deris ZZ, Hazlan SNH, Nasir NSM, Bakar AA, Helmi MAM, Juhari WKW, Kamarudin N, Chong CW, Cleary DW, Clarke SC, Sulaiman LH. Multicentre case-control study of pneumococcal infections among children with pneumonia in Peninsular Malaysia (MY-Pneumo): a study protocol. BMC Public Health. 2024 Aug 20;24(1):2255. doi: 10.1186/s12889-024-19789-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lokman Hakim H Sulaiman, PhD principal investigator
IMU University, Malaysia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, Pneumococcal and Pneumonia Childhood, run by IMU University, Malaysia at 3 sites in Malaysia.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Malaysia. 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?
Results are not available in the source record.
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?
Nasopharyngeal (NP) pneumococcal carriages prevalence rate among young children (time frame: 24 months). 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 NCT04923035, 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 18 Jan 2024.