Evaluating the Effectiveness of a Pneumococcal Immunisation Campaign in a Camp for Internally Displaced People

The outcome is determined at the individual level, through polymerase chain reaction (PCR) microarray analysis of nasal swab samples collected during a cross-sectional, population-representative sample survey of camp residents. The analysis will be stratified by age group (0-11 months, 12-23 months). Vaccine-type serotypes are defined as those that the Pneumosil vaccine (Serum Institute, India) is designed to provide immunity for, and include serotypes serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F and 23F.

The outcome is determined at the individual level, through PCR microarray analysis of nasal swab samples collected during a cross-sectional, population-representative sample survey of camp residents. The analysis will be stratified by age group (0-11 months, 12-23 months). Vaccine-type serotypes are defined as those that the Pneumosil vaccine (Serum Institute, India) is designed to provide immunity for, and include serotypes serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F and 23F.

The outcome is determined at the individual level, through PCR microarray analysis of nasal swab samples collected during a cross-sectional, population-representative sample survey of camp residents. The analysis will be stratified by age group (0-11 months, 12-23 months). Vaccine-type serotypes are defined as those that the Pneumosil vaccine (Serum Institute, India) is designed to provide immunity for, and include serotypes serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F and 23F.

The outcome is determined at the individual level. 'Solicited' indicates that adverse events are identified by study staff using a pre-defined checklist of signs and symptoms and proactive monitoring or follow-up of vaccine recipients. AEFI will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) (version 24.0 or later). Outcome ascertainment will occur through (i) in-person monitoring of vaccine recipients for 30 minutes after vaccine administration, and (ii) exhaustive follow-up of all vaccine recipients 7 days after vaccination, with administration of a structured questionnaire to their parents or caregivers. All AEFI will be graded using a severity scale (0 - none; 1 - mild; 2 - moderate; 3- severe; 4 - very severe; 5 - fatal), and analysis will be stratified by severity and age group (6 weeks to 11 months old, 12 to 23 months old, 24 to 59 months old).

The outcome is determined at the individual level. SAE are defined as any AEFI with severity >= 3. Outcome ascertainment will occur through (i) in-person monitoring of vaccine recipients for 30 min after vaccine administration, (ii) exhaustive follow-up of all vaccine recipients 7 days after vaccination, with administration of a structured questionnaire to their parents or caregivers; (iii) availability of a 24/7 phone number which caregivers of vaccine recipients will be encouraged to contact; (iv) visits to the camp's single primary healthcare facility, during each day on which vaccination takes place, to identify any children presenting for care with a SAE; and (v) availability of a 24/7 phone number which clinicians at the primary healthcare facility will be encouraged to contact. Each SAE will be followed up until resolution. Relatedness of each SAE to vaccine receipt will be classified as 'unrelated', 'unlikely', 'possible', 'probable', 'definite' and 'not assessable'.

The outcome is determined at the individual level, through PCR microarray analysis of nasal swab samples collected during a cross-sectional, population-representative sample survey of camp residents. The analysis will be stratified by age group (24-59 months, 5 to 14 years, 15 to 29 years, 30 to 49 years, 50 years and above). Vaccine-type serotypes are defined as those that the Pneumosil vaccine (Serum Institute, India) is designed to provide immunity for, and include serotypes serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F and 23F.

The outcome is determined at the individual level, through PCR microarray analysis of nasal swab samples collected during a cross-sectional, population-representative sample survey of camp residents. The analysis will be stratified by age group (24-59 months, 5 to 14 years, 15 to 29 years, 30 to 49 years, 50 years and above). Vaccine-type serotypes are defined as those that the Pneumosil vaccine (Serum Institute, India) is designed to provide immunity for, and include serotypes serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F and 23F.

The outcome is determined at the individual level, through PCR microarray analysis of nasal swab samples collected during a cross-sectional, population-representative sample survey of camp residents. The analysis will be stratified by age group (24-59 months, 5 to 14 years, 15 to 29 years, 30 to 49 years, 50 years and above). Vaccine-type serotypes are defined as those that the Pneumosil vaccine (Serum Institute, India) is designed to provide immunity for, and include serotypes serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F and 23F.

The outcome is determined at the individual level, through PCR microarray analysis of nasal swab samples collected during a cross-sectional, population-representative sample survey of camp residents. The analysis will be stratified by age group (0-11 months, 12-23 months, 24-59 months, 5 to 14 years, 15 to 29 years, 30 to 49 years, 50 years and above). Non-vaccine-type serotypes are defined as those that the Pneumosil vaccine (Serum Institute, India) is not designed to provide immunity for, i.e. any serotypes other than 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F or 23F.

The outcome is determined at the individual level, through PCR microarray analysis of nasal swab samples collected during a cross-sectional, population-representative sample survey of camp residents. The analysis will be stratified by age group (0-11 months, 12-23 months, 24-59 months, 5 to 14 years, 15 to 29 years, 30 to 49 years, 50 years and above). Non-vaccine-type serotypes are defined as those that the Pneumosil vaccine (Serum Institute, India) is not designed to provide immunity for, i.e. any serotypes other than 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F or 23F.

The outcome is determined at the individual level, through PCR microarray analysis of nasal swab samples collected during a cross-sectional, population-representative sample survey of camp residents. The analysis will be stratified by age group (0-11 months, 12-23 months, 24-59 months, 5 to 14 years, 15 to 29 years, 30 to 49 years, 50 years and above). Non-vaccine-type serotypes are defined as those that the Pneumosil vaccine (Serum Institute, India) is not designed to provide immunity for, i.e. any serotypes other than 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F or 23F.

The outcome is determined at the individual level, through PCR microarray analysis of nasal swab samples collected during a cross-sectional, population-representative sample survey of camp residents. Bacteriological density is estimated after PCR analysis as copies per milliliter. The analysis will be stratified by age group (0-11 months, 12-23 months, 24-59 months, 5 to 14 years, 15 to 29 years, 30 to 49 years, 50 years and above), and by vaccine-type versus non-vaccine-type serotype colonies. Vaccine-type serotypes are defined as those that the Pneumosil vaccine (Serum Institute, India) is designed to provide immunity for, i.e. 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F or 23F. Non-vaccine serotypes are defined as any other serotype.

The outcome is determined at the individual level, through PCR microarray analysis of nasal swab samples collected during a cross-sectional, population-representative sample survey of camp residents. Bacteriological density is estimated after PCR analysis as copies per milliliter. The analysis will be stratified by age group (0-11 months, 12-23 months, 24-59 months, 5 to 14 years, 15 to 29 years, 30 to 49 years, 50 years and above), and by vaccine-type versus non-vaccine-type serotype colonies. Vaccine-type serotypes are defined as those that the Pneumosil vaccine (Serum Institute, India) is designed to provide immunity for, i.e. 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F or 23F. Non-vaccine serotypes are defined as any other serotype.

The outcome is determined at the individual level, through PCR microarray analysis of nasal swab samples collected during a cross-sectional, population-representative sample survey of camp residents. Bacteriological density is estimated after PCR analysis as copies per milliliter. The analysis will be stratified by age group (0-11 months, 12-23 months, 24-59 months, 5 to 14 years, 15 to 29 years, 30 to 49 years, 50 years and above), and by vaccine-type versus non-vaccine-type serotype colonies. Vaccine-type serotypes are defined as those that the Pneumosil vaccine (Serum Institute, India) is designed to provide immunity for, i.e. 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F or 23F. Non-vaccine serotypes are defined as any other serotype.

The outcome is determined at the population level, as a rate per person-time after division by the camp's estimated population of children aged below 2 years of age, updated through exhaustive census every 6 months. Hospitalisation is defined as admission of a child residing in the camp to a paediatric inpatient facility, with a final diagnosis of acute lower respiratory infection or pneumonia. The outcome is ascertained through a manual search of registers of all paediatric facilities that the camp population can realistically utilise, complemented by perusal of outpatient register records of the camp's single primary healthcare facility, to identify instances of children referred to hospitals. The diagnosis is as per clinical records. The outcome is ascertained retrospectively at baseline (vaccination campaign), and once every 6 months post-vaccination, for 24 months. However, only results after 24 months are analysed.

The outcome is determined at the aggregate (population) level, as a rate per person-time after division by the camp's estimated population of children aged below 5 years of age, which will also be updated through an exhaustive census every 6 months. The outcome is ascertained through consultation of the pharmacy register of the camp's single primary healthcare facility, by tallying the number of single prescriptions issued by the pharmacy to outpatients. Antibiotics are defined as per the World Health Organization's Model List of Essential Medicines. The outcome is ascertained retrospectively through record review conducted at baseline (vaccination campaign), and once every 6 months post-vaccination, for 24 months. However, only results after 24 months are analysed.

The outcome is determined at the individual level, but will be analysed at an aggregate (population) level, with stratification by age group (6 weeks to 11 months old, 12 to 23 months old, 24 to 59 months old, 5 to 14 years old). Before the vaccination campaign, all children aged 6 weeks old to 14 years old living in the camp will be systematically identified and registered. This list will serve as the denominator for the outcome, while the numerator will be children on the list who are successfully vaccinated, as per campaign administrative records. Successful vaccination is defined as injection with two doses of Pneumosil vaccine, spaced 4 weeks apart, in children aged 6 weeks to 11 months old, and one dose of Pneumosil vaccine in children aged 1 to 14 years old.